COVID-19 & Regulatory Surveillance Updates – May 2020
This regulatory surveillance summary reviews key global regulatory developments from May 2020, including covid-19 guidance, emergency regulatory measures, and compliance considerations. By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations and Guidances Health Canada Announces Another Step to Accelerate Access to Health Products for COVID-19, 27 May 2020 The COVID-19 pandemic has led […]
US FDA & Regulatory Surveillance Updates – April 2020
By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Biological Product Deviation Reporting for Blood and Plasma Establishments, March 2020 The US FDA has provided blood or plasma establishments with revised recommendations related to biological product deviation (BPD) reporting. The guidance document is intended to assist blood […]
Regulatory Surveillance Summary | March 2020
By Laurel Hacche and Debra Cortner, SQA Associates Personal Care Products Council Personal Care Products Council (PCPC) COVID-19 Summary, 20 March 2020 In an effort to comply with health authorities’ recommendations for social distancing and in an abundance of caution, PCPC has closed their offices, and staff is working remotely to maintain business continuity and […]
Warning Letter Updates: Regulatory Surveillance Summary – Feb 2020
This regulatory surveillance summary reviews key global regulatory developments from February 2020, including warning letter issuances, FDA enforcement actions, and compliance updates. By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of […]
Health Canada Regulatory Updates: Regulatory Surveillance Summary – January 2020
This regulatory surveillance summary reviews key global developments from January 2020, including Health Canada guidance, regulatory updates, and international compliance considerations. By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations/Guidances Regulation of Vaping Products in Canada, December 2019 On 19 December 2019, Health Canada announced the final “Vaping Products Labelling and Packaging Regulations,” creating new […]
Drug Recall Updates: Regulatory Surveillance Summary – December 2019
This regulatory surveillance summary reviews key global regulatory developments from December 2019, including drug recall actions, FDA warnings, and compliance updates. By Laurel Hacche, SQA Associate United States Food and Drug Administration (US FDA) Guidances (Devices and Drugs) Device Guidance: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations, October 2019 This […]
EU MDR Regulatory Updates October 2019: Regulatory Surveillance Summary
EU MDR Regulatory Updates October 2019 – Regulatory Surveillance Summary This regulatory surveillance summary outlines key EU MDR regulatory updates from October 2019, highlighting guidance, implementation considerations, and regulatory developments affecting medical device manufacturers. By Boudewijn Jong, SQA Associate, Netherlands Synopsis On 20 May 2020, the new European Union Medical Device Regulation (EU MDR) will […]
Regulatory Surveillance Summary July 2019
This regulatory surveillance summary reviews key global developments, including IPEC Federation guidance, regulatory updates, and industry standards published in July 2019. SQA Regulatory Surveillance Summary for Q2, 2019 International Council for Harmonization (ICH) Guidance ICH Harmonized Guideline, Optimization of Safety Data Collection, E19, Draft April 2019 This Guideline is intended to provide internationally harmonized guidance […]
Regulatory Surveillance Summary March 2019
This regulatory surveillance summary highlights key FDA recalls and warnings, draft guidances, and regulatory developments impacting the life sciences industry in March 2019. Association for the Advancement of Medical Instrumentation (AAMI) AAMI News: Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain – Computer Interfaces, April 2019 For people affected by paralysis or an amputation, devices […]
Regulatory Surveillance Summary Winter 2018
European Federation for Cosmetic Ingredients (EFfCI) No updates noted for EFfCI Good Manufacturing Practice Working Group. European Medicines Agency (EMA) Regulatory Science to 2025 – Launch of Six-Month Public Consultation, 19 December 2018 EMA has published its draft ‘Regulatory Science to 2025’ strategy for a six-month public consultation . This is a proposed plan for advancing the […]