This pharmaceutical regulatory news summary highlights key global regulatory, compliance, and enforcement developments from Q2 2025. The update covers major actions and guidance issued by health authorities including ANVISA, FDA, EMA, NMPA, MHRA, Health Canada, WHO, and other global regulators impacting pharmaceuticals, biologics, medical devices, and combination products.
Written by Laurel Hacche, Debra Cortner, and Jim Qi
Agência Nacional de Vigilância Sanitária (ANVISA) – Pharmaceutical Regulatory News
A joint operation carried out on 16 April 2025 mobilized agents of the Public Ministry of Paraná (MP-PR) and ANVSA to combat the sale of illegal medical and dental equipment in Ponta Grossa, Paraná. A dentist, appointed as one of the largest merchants of orthodontic products in the country, was the target of two search and seizure warrants, at his residence and in a city clinic. The investigation revealed that portable x-ray and ultrasound devices, as well as drills and files, all without proper registration at ANVISA, were imported from China and sold via the internet and social networks, putting the health of patients and professionals at risk. During the action, cell phones, computers and several suspicious medical devices were seized. According to the MP-PR, there are indications that the scheme involves other people, and may characterize a criminal association. In addition, the values obtained illegally from the sale of this equipment are being calculated.
Notification of Pre-Qualification Inspection of Synthetic Medicines, 24 April 2025
ANVISA has served notification that Pre-Qualification Inspections (IPQs) for manufacturers of synthetic medicines will soon begin. The IPQ is an optimized assessment tool, based on risk criteria, provided for in the Resolution of the Collegiate Board (RDC) 823/2023. Its objective is to evaluate whether a given company can consistently comply with the requirements for registration and post-registration of medicines. Pre-qualification can be applied to synthetic medicines and processes still in the development phase, or to petitions related to these medicines awaiting analysis at ANVISA. Thus, aiming at the transparency of the regulatory process to be initiated, POP-F-ANVISA-221 is now available, with detailed instructions on the IPQs, as well as the forms related to it.
ANVISA issued an alert about a very rare adverse event, which can cause sudden loss of vision, associated with the use of drugs containing semaglutide – such as Ozempic®, Rybelsus® and Wegovy®. ANVISA has requested the inclusion, in the leaflets of these drugs, of the “very rare” adverse reaction called non-arteritic anterior ischemic optic neuropathy (NAION). The decision was made after analysis by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), which identified NAION as a possible adverse event of semaglutide. In the Brazilian system for reporting adverse drug events, VigiMed (VigiLyse database), 52 notifications of suspected eye disorders related to semaglutide were recorded. This enforcement action forms part of ongoing pharmaceutical regulatory news from ANVISA aimed at combating illegal medical product distribution and protecting patient safety.
China Pharmaceutical Regulatory News – National Medical Products Administration (NMPA)
Update of the GMP Guideline for Sterile Medicinal Products in China, 01 April 2025
Following the publication of the revision to EudraLex, Volume 4, Annex 1, Manufacture of Sterile Medicinal Products, the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) have published comparable documents. The NMPA has published a draft regarding new GMP requirements for sterile medicinal products on 17 March 2025. The draft defines precise requirements for the manufacture, control and quality management of such products. The focus is on the introduction of a Comprehensive Contamination Control Strategy (CCS) that integrates all processes, facilities and employee activities. The aim is to minimize the risk of microbial, particulate or pyrogenic contamination at every stage of production.
NMPA Announces Issuing the Pharmaceutical Excipients and Packaging Materials Annexes, 11 June 2025
The NMPA has organized the formulation of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex. These serve as supplementary provisions for the Good Manufacturing Practice for Drugs (2010 Revision) in accordance with Article 310 of the Good Manufacturing Practice for Drugs (2010 Revision). They are hereby issued (see Annexes 1 and 2), and the relevant matters concerning the strengthening of the quality supervision of pharmaceutical excipients and pharmaceutical packaging materials by establishing a comprehensive Quality Management System (QMS) which includes:
- Implementation of the primary responsibility for product quality while addressing organizational requirements, procedural controls, records management, supplier qualification and routine assessment, and production controls.
- Application of change control, including risk assessment, and maintenance of registration requirements, including notification to drug Marketing Authorization Holder(s) (MAH), as appropriate.
- Strengthening external communication and cooperation, including the receipt of drug MAH audits, ongoing assessment of complaints, and addressing any required actions associated with recalls.
Additional requirements include:
- Strengthening the management of pharmaceutical excipients and pharmaceutical packaging materials usage by MAHs.
- Strengthening the supervision and management by drug regulatory authorities.
This announcement shall come into force on 01 January 2026.
European Union Pharmaceutical Regulatory News – European Commission (EC)
EU Pharma Reform: What the 2025 Pharma Package Means for Medicines Development, 17 June 2025
The European Union is on the cusp of a historic transformation in pharmaceutical regulation. On 04 June 2025, the Council of the European Union agreed on its position regarding the sweeping Pharma Package, a major legislative initiative aimed at making the EU pharmaceutical sector more fair, competitive, and resilient. With negotiations now set to begin with the European Parliament, these changes may soon reshape how medicines are developed, regulated, and accessed across the EU. The Pharma Package marks the most significant revision to EU pharmaceutical legislation in over 20 years. For professionals working in regulatory affairs, clinical trials, and medical affairs, these proposed changes could impact everything from approval timelines and data protection to strategic planning for market access. The package includes two core proposals:
- A regulation laying down EU procedures for the authorization and supervision of medicinal products and rules for the European Medicines Agency (Council of the EU, 2025b).
- AÂ directiveestablishing a Union code for medicinal products (Council of the EU, 2025c).
Key objectives of the legislation are to:
- Ensure equitable access to medicines across all EU member states.
- Enhance the competitiveness of the pharmaceutical industry by reducing regulatory burdens.
- Improve medicine supply chain security and transparency.
- Enforce stronger environmental rules in pharmaceutical manufacturing and distribution (Council of the EU, 2025a).
MDCG Guidance Clarifies Requirements for AI Products Under AI Act, MDR, and IVDR, 24 June 2025
The EC’s Medical Device Working Group (MDCG) has published a guidance outlining how the Medical Device Regulation (MDR), In Vitro Diagnostics Regulation (IVDR), and the recently enacted Artificial Intelligence Act (AIA) interplay when applied to certain artificial intelligence (AI) products. The guidance details expectations on how manufacturers should address risk, conformity assessments, and predetermined changes to the products. The frequently asked questions and answers document aims to help manufacturers understand their responsibilities under the three European texts. It also clarifies terms used under the different texts and discusses legal requirements, clinical and performance testing, conformity assessments, and more.
On 26 June 2025, the European Commission published Commission Implementing Regulation (EU) 2025/1234 in the Official Journal of the European Union. This regulation significantly expands the possibility of using electronic instructions for use (e-IFU) for medical devices. Previous restrictions allowing e-IFU mainly for stationary or active devices have now been lifted. The new rules allow all manufacturers of devices intended solely for professional users to forgo paper-based instructions. The regulation permits broader use of e-IFUs, provided that certain conditions specified in the amendment are met. This includes:
- Devices covered by Regulation (EU) 2017/745 (MDR), provided they are intended exclusively for professional users
- Accessories to devices covered by Regulation (EU) 2017/745 (MDR)
- Mon-medical products listed in Annex XVI to the MDR
- Legacy devices placed on the market under Article 120 MDR.
Crucially, the use of e-IFUs is prohibited if there is any risk that the device may end up in the hands of lay users, even if that is not the intended purpose. Manufacturers must have documented justification and control systems to demonstrate this risk has been eliminated.
European Medicines Agency (EMA)
Streamlining Development and Assessment of Biosimilar Medicines, 01 April 2025
EMA is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. With over two decades of experience in evaluating biosimilar medicines, EMA anticipates that this approach will improve access to biosimilars for patients in the EU and ensure that Europe is an attractive market to develop these treatments. The approach, which is outlined in a new draft reflection paper, would potentially reduce the amount of clinical data required for the development and approval of biosimilar medicines. Building on extensive experience with biosimilar medicines and advances in analytical methods, the draft reflection paper suggests that demonstrated structural and functional comparability, together with comparative data on how the body interacts with the medicines (pharmacokinetic data), may be sufficient to demonstrate similarity with the reference medicine. This could potentially reduce the need for extensive clinical efficacy studies. Waiving certain clinical data requirements would simplify the development and evaluation process while maintaining the highest standards of safety and efficacy. This more streamlined approach would ultimately ensure wider availability of biosimilar medicines to patients in the EU. These developments represent significant pharmaceutical regulatory news for companies involved in medicines development, clinical trials, and EU market access planning.
Leveraging the Power of Data for Public and Animal Health, 07 May 2025
The EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan entitled Data and Artificial Intelligence (AI) in Medicines and Regulation, 2025 to 2028. This workplan sets out how the European medicines regulatory network plans to leverage large volumes of regulatory and health data as well as new tools to encourage research, innovation, and to support regulatory decision making for better medicines that reach patients faster. The workplan lays out a roadmap for managing, analyzing, and sharing data across the network, while adhering to high security and ethical standards. It also provides a framework for coordination to address new legislative initiatives in the European Union (EU), notably the pharmaceutical legislation, the European Health Data Space (EHDS), the Interoperable Europe Act, and the AI Act.
A New Guideline for Advanced Therapy Medicinal Products, 24 May 2025
The European Medicines Agency (EMA) has released a draft guideline on quality, non-clinical, and clinical requirements for investigational Advanced Therapy Medicinal Products (ATMPs) in clinical trials for public consultation. This guideline outlines the structure and data requirements for clinical trial applications, covering both exploratory and confirmatory trials for ATMPs. It addresses multidisciplinary aspects including development, manufacturing, quality control, and both non-clinical and clinical development. The guideline details requirements for exploratory trials, such as First in Human studies, and confirmatory trials, with a view toward an eventual Marketing Authorization Application (MAA).
Health Canada
Health Canada is warning about unauthorized injectable peptide drugs seized from the Optimum Wellness Centre on Southport Road in Calgary, Alberta. Peptide drugs affect the body’s functions and most injectable peptides are regulated as prescription drugs in Canada. Health Canada has not authorized any of the products seized, which means they have not been assessed for safety, efficacy and quality and they are illegal to be sold in Canada. Unauthorized injectable drugs may pose serious health risks. They could:
- Cause infection, allergic reactions, possible interactions with other medications an individual might be taking, and other poor outcomes.
- Contain high-risk ingredients, additives or contaminants that may or may not be listed on the label.
- Not have been manufactured or stored safely.
Non-Compliant Inspection Rating for Canadian Custom Packaging Company, 08 April 2025
Canadian Custom Packaging Company located in Toronto, Ontario, received a non-compliant rating from a GMP domestic inspection that started on 08 April 2025. Key findings identified inadequacies in the following areas:
- Quality Control department personnel
- Assessment of the release for finished products
- Ongoing stability program
- Evaluation of production processes, equipment, and/or materials
- Equipment qualification, including computerized systems
- Facility design, maintenance, and sanitation
- Temperature and/or humidity control
- Change Control
- Data Integrity
JAMP Valproic Acid Oral Solution Recall, 18 April 2025
JAMP Pharma Corporation is recalling three lots of JAMP Valproic Acid Oral Solution after receiving complaints of large solid crystals that do not dissolve when the bottles are shaken, and that are difficult to break apart. The company has indicated that the crystals are sucrose (a type of sugar). The crystals may pose a choking hazard, especially in young children or people with difficulty swallowing. JAMP Valproic Acid Oral Solution is a prescription drug usually taken by adults and children two years of age and older to control epilepsy, a disorder of the brain that causes seizures.
Health Canada is warning consumers about the serious health risks, including death, of inhaling nitrous oxide products, also known as laughing gas and by various street names, such as Whippets, Hippy Crack, NOS, and Nang, for recreational purposes. Examples of seized products include:
- Bamboozle
- Need Whip
- Primewhip
- Primewhip XL
- Space Gas
In Canada, nitrous oxide sold for inhalation is a drug and can only be administered by an authorized health care professional for legitimate and safe uses, such as in medical and dental procedures for sedation and pain relief. It is also in cream dispensers and other food tools where it is not meant to be inhaled. When inhaled—or “huffed”—nitrous oxide can cause euphoria and relaxation. It can also cause serious adverse effects such as:
- Loss of consciousness and in some cases, death
- Birth defects
- Anemia, vitamin B12 deficiency
- Impaired bowel and bladder function
- Confusion, agitation, delusions, hallucinations, paranoia and depression
- Increased heart rate, palpitations, low blood pressure, heart attack and stroke
- Lack of oxygen in the body (asphyxia), blood clots in the extremities and in the lungs, and air leaks into the space between the lung and chest wall (pneumothorax)
- Tingling, numbness and weakness of the limbs and extremities (fingers and toes), uncoordinated walking and falls
- Nerve damage, spinal cord degeneration, prolonged pain and, in severe cases, permanent paralysis
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidances – Quality, Efficacy, Multidisciplinary, and Safety
ICH Revises Q1 Guideline, Advancing Stability Testing Standards, 24 April 2025
In April 2025, ICH reached Step 2 of a long-awaited revision to its stability guidance, releasing a draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades. It is a consolidated revision that will supersede the ICH Q1A to Q1F guidelines and ICH Q5C (for biotechnological products), unifying them into a single comprehensive guideline. The revision was prompted by the need to streamline and modernize stability requirements, address ambiguities in the previous guidances, and incorporate scientific advances and new product types. Notably, the ICH Q1 revision integrates principles from other ICH quality guidelines to reinforce a science- and risk-based approach to stability testing. It also introduces guidance for emerging therapies and methodologies, such as Advanced Therapy Medicinal Products (ATMPs) and predictive stability modeling.
ICH E20 Draft Guideline is Available Now on the ICH Website, 25 June 2025
The ICH E20 draft guideline on Adaptive Design for Clinical Trials has reached Step 2b of the ICH Process on 25 June 2025 and entered the Step 3 public consultation period. The draft Guideline provides guidance on confirmatory clinical trials with an adaptive design intended to evaluate a treatment for a given medical condition within the context of its overall development program. The focus of this guideline is on principles for the planning, conduct, analysis, and interpretation of trials with an adaptive design intended to confirm the efficacy and support the benefit-risk assessment of a treatment.
International Pharmaceutical Excipients Council (IPEC)
Now Available: IPEC Risk Assessment Guide, 06 May 2025
IPEC Federation announces the availability of the IPEC Risk Assessment Guide for Pharmaceutical Excipients – Risk Assessment for Excipient Manufacturers (Version 1, 2025). First published as a joint IPEC-Americas and IPEC Europe Guide in 2017, it is now issued as an IPEC Federation document. Widely applicable globally, it has been updated to reflect current practices and streamlined by removing duplicated content from referenced materials. The IPEC Risk Assessment Guide provides detailed guidance on evaluating risks to excipient quality, supporting excipient manufacturers and distributors in making consistent, risk-based decisions, and serves as a resource for excipient users assessing their suppliers’ risk strategies.
International Organization for Standardization (ISO)
ISO 11137-1 is important as it ensures that medical devices are free from viable microorganisms, which is critical for patient safety. The standard describes how to minimize the microbial presence on devices before sterilization and outlines the methods to validate and control the sterilization process. Edition 2 of ISO 11137-1 that was published in April 2025 includes several significant changes:
- Addition of New Normative References: Incorporates ISO 13004 and ISO/ASTM 52628 to align with the latest dosimetry practices and terminology.
- Updated Clause Structure: Revisions in Clause 4 to better align with ISO/TC 198 documents, enhancing the clarity and application of the standard.
- Increased Limits for Induced Radioactivity: Updates on allowable limits for electron and X-ray induced radioactivity, reflecting new scientific evidence and technological advancements.
- Enhanced Control Functions: New requirements to prevent control failures during the sterilization process, ensuring the integrity of process parameter recording.
- Simplified Content on Dose Verification: Streamlining the transference of verification or sterilization doses based on new data, improving operational efficiency.
ISO 14644-5:2025 Cleanrooms and Associated Controlled Environments Part 5: Operations, May 2025
ISO 14644-5:2025 specifies requirements for the establishment of an Operations Control Programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring. This standard specifies operational requirements that relate to:
- Providing a system that specifies policies and operational procedures for maintaining cleanliness levels
- Training of personnel
- Transferring, installing and maintaining stationary equipment
- Transferring material and portable equipment into and out of the cleanroom
- Maintaining a personnel management program that includes a gowning program
- Maintaining a cleaning programme that addresses special cleaning
- Maintaining a cleanroom maintenance program
- Establishing an appropriate monitoring program
The standard gives additional information in annexes for personnel management, gowning, training, and cleaning.
International Society for Pharmaceutical Engineering (ISPE)
Good Practice Guide: Digital Validation, April 2025
The ISPE Good Practice Guide: Digital Validation considers how increased adoption of Digital Validation Tools (DVTs) in the life sciences industry can support a growing commitment to data integrity, operational efficiency, and regulatory compliance. However, the transition from traditional, paper-based validation to a digitally integrated framework remains a complex challenge. This guide offers practical guidance and best practices for navigating the complexities of implementation and operation. Developed by a global team of experts in validation, regulatory compliance, quality assurance, and digital transformation, this guide presents real-world insights, case studies, and structured methodologies to facilitate the successful integration of digital validation into business operations. It explores regulatory considerations, system selection, data management strategies, and compliance frameworks, providing organizations with the necessary tools to enhance validation efficiency while maintaining regulatory rigor.
Good Practice Guide: Validation 4.0, June 2025
The ISPE Good Practice Guide: Validation 4.0 provides a comprehensive approach to ensuring product quality and patient safety throughout a pharmaceutical product’s lifecycle. A Holistic Control Strategy (HCS) in this context means moving beyond traditional, static, upfront and localized validation controls to a dynamic, data-driven, and continuous approach to managing risks and quality along the broader value chain. The guide is intended to be an early introduction into modern validation thinking in an increasingly digital world that offers new capabilities for managing and controlling manufacturing processes. The structure starts with an overview of methodology considerations, covers foundational enablers, required capabilities, and a section on real-life case studies that have been selected to explain aspects to consider when adopting Validation 4.0 in practice.
Medicines and Healthcare Products Regulatory Agency (MHRA)
Clinical Trials Regulations Signed into Law, 11 April 2025
New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out begins on 11 April 2025 to deliver the most significant update to UK clinical trials regulation in two decades with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research. The updated regulations are designed to put participants firmly at the center of how trials are run, while supporting a faster, more streamlined approvals, making it easier to test new treatments in the UK. The MHRA is committed to implementing a flexible and risk-proportionate regulation of clinical trials, which accelerates patient access to potentially life-saving medicines without compromising safety.
On 16 June 2025 a landmark reform of how medical devices are regulated in Great Britain takes effect, as part of the MHRA’s broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulations require device manufacturers to actively track the safety and performance of products already in use. Key changes introduced by the new PMS device regulation include:
- Enhanced collection of real-world data
- Expanded scope for incident reporting
- Shorter timelines for reporting serious incidents
- Updated trend reporting and summary reporting
- Clearer duties for risk mitigation and communication
Parenteral Drug Association (PDA) – Technical Reports and Guidances
Points to Consider No. 12: Restricted Access Barrier Systems, June 2025
This PDA Points to Consider No. 12: Restricted Access Barrier Systems is designed to communicate PDA’s thoughts and considerations pertaining to the design, operation, and use of Restricted Access Barrier Systems (RABS) for aseptic processing, processes subjected to terminal sterilization and low bioburden, while encouraging further dialog with industry, health authorities, and suppliers of technologies and materials.  This document considers the evolution and needs of the modern, global, sterile, healthcare product manufacturing industry. This document does not represent a standard or regulatory guidance.
PDA Survey: 2025 Transportation Validation Benchmarking Survey, June 2025
The PDA 2025 Transportation Validation Benchmarking Survey aimed to gather industry benchmarking data on transportation qualification strategies within the pharmaceutical and biopharmaceutical industry. Specifically, the goal was to examine the application of simulated data to better understand how transportation conditions impact drug product quality, emphasizing the importance of ensuring product quality during transit. The survey focused on evaluating transportation through simulated environments versus real-world qualification of temperature-controlled shipping systems. To contextualize responses, the survey included general demographic questions and was structured into product-specific, supply-chain-focused, and regulatory strategy-driven categories. The manufacturers of small molecule medicines and oral dosage forms were not a target audience for this survey.　
Therapeutic Goods Administration (TGA)
Counterfeit Ozempic Injection Pens Detected, 03 April 2025
Consumers and health professionals should be aware that further examples of counterfeit Ozempic-labelled products have been stopped at the Australian border. These injection pens may pose a serious risk to your health and should not be used. Consumers should be aware that counterfeit products have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation. The products subject to this alert exhibited typographic inconsistencies in packaging compared to legitimate Ozempic products, including differences in spacing and bolding of the text. This is a new issue identified, distinct from the previous alert issued in September 2024 regarding counterfeit injection pens labelled as Ozempic that contained insulin. Â Consumers should be warned that manufacturers of counterfeit goods are producing products that, to the untrained eye, may appear legitimate, highlighting the need to purchase medicines from legitimate sources.
Court Proceedings initiated Against Philips Electronics Australia Limited, 03 Jun 2025
The TGA has commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited (PEAL) for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements. These included devices used by people at home who suffer from sleep apnea, and devices used by patients who need help breathing. The devices contained a Polyester-Based Polyurethane (PE-PUR) foam used for noise suppression. There was a real risk of the PE-PUR foam degrading and then particulates being inhaled or ingested by the patient. As a result, these devices were recalled in 2021.
Potential harm from short and intermediate exposure from PE-PUR degradation included skin, eye and respiratory tract irritation, inflammatory response, headache, asthma, effects on the user’s reproductive system and neoplasia. Potential harm from long term exposure included cytotoxic, genotoxic and carcinogenic effects. In addition, for a particular model (Trilogy 100), PEAL supplied devices with a silicone foam as a replacement for devices containing the PE-PUR foam. For the silicone foam replacement, there was a real risk of the silicone foam dislodging from its position and blocking the air pathway. This could stop the device from working, resulting in ventilation failure or underventilation. This could then result in hypoventilation, hypoxemia, hypercapnia and asphyxia.
The TGA alleges that, due to the risk of the PE-PUR foam degrading and silicone foam dislodging, the devices supplied from 02 June 2019 to 13 October 2022 (depending on the device) were unsafe, did not perform as intended, and were therefore unlawfully supplied.
New Regulations to Strengthen Medical Device Patient Safety, 30 June 2025
Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the identification and management of device-related safety concerns. TGA will now receive clearer identification and more detailed information about devices, allowing it to respond more quickly as and when issues are found. Patient safety will be strengthened through several key initiatives:
- Hospitals to report medical device adverse events to TGA
- Improved and clearer national recall processes
- Unique Device Identification (UDI) system
For the UDI system, manufacturers supplying medical devices in Australia must use barcodes to identify their products on all packaging and labelling and submit this data to the TGA. Mandatory compliance with the UDI system for implanted devices will start from July 2026.Â
United States Pharmaceutical Regulatory News – FDA Regulations and Guidances
The FDA is announcing the availability of a draft guidance for industry entitled: Replacing Color Additives in Approved or Marketed Drug Products. If a color additive is replaced in a drug product, information to support the change should be retained and available at the manufacturing facility. Additionally, this draft guidance recommends that New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) holders submit information to support color additive replacements in Changes Being Effected in 30 days (CBE-30) supplements. Although a qualitative or quantitative change to an inactive ingredient is generally considered a major change, in many cases, replacing a color additive with one that is listed in the color additive regulations is unlikely to adversely affect the identity, strength, quality, purity, or potency of the drug product. Â Therefore, this draft guidance recommends a CBE-30 for such a change.
The Guidance for industry, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. The guidance addresses the following topics:
- General Principles
- Using a Secure Product Development Framework (SPDF) to Manage Cybersecurity Risks
- Cybersecurity Transparency
- Cyber Devices
FDA Draft Guidance Outlines UDI Requirements for Combination Products, June 2025
FDA has released draft guidance outlining when combination products with device constituent parts are subject to unique device identifier (UDI) requirements. A combination product can include a single entity combination product with two or more drug/device/biological product components, a co-packaged combination product with two or more drug/device/biological products, a co-packaged combination product with two or more drug/device/biological products packaged separately but intended to be used together, or a cross-labeled combination product consisting of a drug/device/biological product that is packaged separately but intended to be used with another drug/device/biological product. In general, FDA states that a combination product with device constituent parts needs to follow UDI requirements, but the entire combination product may be exempt if each individual constituent part is not subject to UDI requirements. This echoes comments made by agency officials in other venues about how sponsors should treat UDI requirements in combination products that involve device constituent parts.
United States Food and Drug Administration (FDA) – Recalls
Bausch + Lomb Corporation), a leading global eye health company announced a voluntary recall of Intraocular Lenses (IOLs) on its enVista platform. The recall is in response to an increased number of reports of Toxic Anterior Segment Syndrome (TASS), and includes specified lots of the enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric, as well as enVista monofocal and enVista monofocal Toric IOL models in the United States. TASS, a potential complication in any cataract surgery, is an inflammatory reaction inside the eye that can have a variety of causes. When it occurs, this complication typically appears 12 – 48 hours after eye surgery. All enVista TASS cases reported to Bausch + Lomb to date responded quickly to treatment, and none have required removal of the lens.
Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs to the consumer level. The products are being recalled due to potential microbial contamination identified as fungi in cotton swab components. Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries. The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions. To date, no serious adverse events associated with the affected product have been reported.Â
In May 2025, Medtronic issued a voluntary recall notification to global customers related to specific Newport HT70 and HT70 Plus ventilators and certain related Newport service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall. With this recall, Medtronic is advising discontinuation of clinical use of the affected devices. Investigation into customer complaints identified two separate capacitors on one of the ventilator’s controllers Printed Circuit Board Assembly (PCBA), that, in case of failure, may result in:
- The ventilator shutting down during use, or
- The shutdown alert alarm failing to sound effectively.
If a ventilator fails and does not provide adequate ventilation, the patient may not be able to breathe on their own, leading to low oxygen levels, high carbon dioxide levels, and potentially severe consequences like brain injury or death. There have been 63 Medical Device Reports (MDRs) associated with this issue, including two serious injuries and one death. HT70 and HT70 Plus ventilators are intended for use by home users, as well as for infant and pediatric patients who may be at higher risk of injury or death due to unanticipated ventilator failures.
United States Food and Drug Administration (FDA) – Warning Letters
EpiCare Acquisitions, LLC, Warning Letter, 21 March 2025
EpiCare Acquisitions, LLC, a manufacturer of the EpiCare-Zenith Family of Laser systems, received a Warning Letter on 21 March 2025. This Warning Letter was a result of an FDA inspection that was conducted from 12 November 2024 to 13 December 2024 at the EpiCare Acquisitions, LLC, Lawrenceville, New Jersey facility. The 483 observations sited including the following concerns:
- Failure to establish and maintain procedures for validating the device design.
- Failure to maintain complaint files and failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
- Failure to establish and maintain procedures for implementing corrective and preventive action
- Failure to maintain Device History Records (DHR’s).
- Failure to maintain Device Master Records (DMR’s)
- Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.
Big Pharma USA, Warning Letter, 17 June 2025
Big Pharma USA received a Warning Letter on 17 June 2025. The FDA has observed that the company introduced into interstate commerce unapproved and misbranded opioid drug products. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers. The company’s description of tramadol marketed as Generic Tramadol 200 mg, Tramadol 200 mg Tabletas, and Tramadol 200 mg drug (L011 Pill) includes the following statements:
- This medication is approved by the FDA for managing moderate to severe pain mainly in adults.
- Tramadol 20 mg medicine acts in the brain and spinal cord (Central Nervous System (CNS)) to treat pain.
The company’s description of oxycodone marketed as Generic Oxycodone 20 mg and Oxycodone 20 mg (M 20 Pill) includes:
- Oxycodone 20 mg (M 20 Pill) is a strong opioid medication that can be used for treating mild to severe pain.
- M 20 pill round [sic] acts by blocking the transmission of pain signals to the brain.
These products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs, because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA. No approved applications are in effect for these products. Additionally, FDA has observed that www.bigpharmausa.com offers prescription drugs for sale without a prescription. Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.bigpharmausa.com jeopardizes patient safety and misbrands the drugs.
World Health Organization (WHO)
Medical Product Alert No2/2025: Falsified Healmoxy (Amoxicillin) Capsules, 500 mg, 23 April 2025
A WHO Medical Product Alert was issued on 23 April 2025 for four batches of falsified Healmoxy Capsules, 500mg. The falsified batches were detected in Cameroon and the Central African Republic and were reported to the WHO in March 2025. The active pharmaceutical ingredient in genuine Healmoxy capsules is amoxicillin. It is an antibiotic used to treat a variety of bacterial infections, including middle ear infections, pneumonia, skin infections, dental infections, and urinary tract infections. The four batches for this alert are identified as falsified as they deliberately misrepresent their identity, composition, and source due to the following concerns:
- Analysis of samples of the falsified Healmoxy found the capsules did not contain the stated active ingredient, specifically amoxicillin.
- At least two of the falsified batches displayed inconsistent formats for manufacture and expiry dates. Dates on the falsified batches were displayed as day/month/year in eight digits (e.g., 10/01/2027).
Medical Product Alert No3/2025: Falsified Imfinzi (Durvalumab) Injection, 500 mg/10 mL, 14 May 2025
A WHO Medical Product Alert was issued on 14 May 2025 for three batches of falsified Imfinzi (Durvalumab) Injection 500 mg/10 ml. The falsified batches were detected in the Islamic Republic of Ian and Türkiye and were reported to the WHO in March 2025. WHO previously issued Medical Product Alert N°5/2024 regarding another falsified batch of Imfinzi that was detected in Armenia, Lebanon, and Türkiye. Imfinzi is a sterile concentrate for infusion. It contains the active pharmaceutical ingredient durvalumab, which is a monoclonal antibody. As monotherapy, it is indicated for the treatment of Non-Small Cell Lung Cancer (NSCLC) in adults. The three batches for this alert are falsified as they deliberately misrepresent their identity, composition, and source. The genuine manufacturer, AstraZeneca, has identified multiple visual discrepancies in the falsified products. AstraZeneca has confirmed that the products mentioned in this alert are indeed falsified. Specifics for each of the batches are provided below:
- Lot BAZR – This is a genuine lot number for distribution only in India. The falsified product shows discrepancies in the packaging artwork and text placement, with some text missing.
- Lot BBEG – This is a genuine lot number for distribution only in Egypt. The falsified product shows discrepancies in the packaging artwork and text placement, with some text missing. The product price (in Egyptian Pounds) is also missing.
- Lot AVZT – This lot number is not recognized by the genuine manufacturer. Any Imfinzi product with this lot number is considered falsified.
In a move to strengthen global efforts against waterborne disease, WHO has released 54 new WASH-related pathogens technical background documents. These documents capture the latest science on pathogens linked to drinking-water and sanitation systems. The newly published documents offer a detailed overview of pathogens that pose a risk through water, sanitation, or both. WHO has included documents for several pathogens not traditionally considered waterborne, but for which questions have been raised about possible transmission through drinking water. Each background document provides a concise summary of the current science. The summary includes information on human health impacts, disease patterns, modes of transmission, and sources of fecal contamination. The profiles also detail how these pathogens occur in the environment (including various parts of the water cycle) and how they are detected, prevented, and managed within drinking water and sanitation systems.
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