SQA News | Summer 2019
Wins & Challenges It was a crazy summer for the McKay family. After dropping our son off at LAX to attend college overseas, my wife Carrie and I headed to Hermosa Beach to have our first lunch as official “Empty Nesters.” It was emotional, somewhat awkward, and bittersweet in many ways. Steph and Johnny are […]
Regulatory Surveillance Summary 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 on an optimized approach to safety data collection in some late-stage pre-approval or post-approval studies when the safety profile of a […]
SQA News | Spring 2019
Wins & Challenges Summer has started, along with some amazing scenery in California, since we’ve had periodic rain with a generous amount of sun. SQA has been evolving the past few months as well. There has been a lot of concentration on balancing the resources needed to provide our clients the results expected. This has […]
Regulatory Surveillance Summary 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Association for the Advancement of Medical Instrumentation (AAMI) AAMI News: Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain – Computer Interfaces, April 2019 For people affected by paralysis or an amputation, devices that can bridge the gap between the brain and computers—called brain–computer interfaces (BCIs)—hold great promise. These devices can be implanted into the nervous […]
SQA News | Winter 2019
Wins & Challenges Out here in Los Angeles, we’re used to summer weather starting around now, but I still find myself reaching for a jacket every morning. Despite our lack of success in avoiding weather, we’ve been very successful in learning and growing as a company thanks to some leadership initiatives that have set us […]
Regulatory Surveillance Summary Winter 2018
European Federation for Cosmetic Ingredients (EFfCI) No updates noted for EFfCI Good Manufacturing Practice Working Group. Click here for more information 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 […]
Regulatory Surveillance Summary for August 2018
China GMP WHO Statement on Rabies Vaccine Incident in China: 25 July 2018 The World Health Organization (WHO) fully supports the China National Drug Administration’s (CNDA’s) actions to withhold problematic batches of rabies vaccine and ensure they are not placed on the market. During an unannounced inspection at the manufacturing site of Changchun Changsheng Life […]
SQA News | Fall 2018
Wins & Challenges I usually end up writing these articles while flying. I find it peaceful, and for some reason being on a plane lets me open up my mind. I’m sitting next to my lovely wife Carrie, en route to celebrate a close friend’s 50th birthday. I can’t believe we are getting that old, […]
Regulatory Surveillance Summary for July 2018
United States Food and Drug Administration (US FDA) Guidances Use of Electronic Health Record Data in Clinical Investigations: July 2018 US FDA has published a guidance for industry entitled Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry. The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review […]
Regulatory Surveillance Summary for June 2018
European Federation for Cosmetic Ingredients (EFfCI) European Federation for Cosmetic Ingredients (EFfCI) Good Manufacturing Practice (GMP) for Cosmetic Ingredients, Revision 2017 This document incorporates existing GMP principles, World Health Organization (WHO) GMP Guidelines for Excipients, International Pharmaceutical Excipients Council (IPEC) GMP for Bulk Pharmaceutical Ingredients 2006, and International Quality Management System requirements as developed […]