SQA Regulatory Surveillance Summary | August 2020
By Laurel Hacche and Debra Cortner, SQA Associates European Pharmacopoeia (Ph. Eur.) Recombinant Factor C: New Ph. Eur. Chapter, 01 July 2020 Published in Ph. Eur. Supplement 10.3, the new general chapter 2.6.32., “Test for bacterial endotoxins using recombinant factor C,” describes a test for bacterial endotoxins (BET) that can be used as an alternative to the […]
SQA Regulatory Surveillance Summary | July 2020
Coronavirus Regulatory Guidance and Emergency Measures – July 2020 This regulatory surveillance summary reviews key global regulatory developments from July 2020, including coronavirus guidance, emergency regulatory measures, and compliance considerations. By Laurel Hacche and Debra Cortner, SQA Associates European Medicines Agenda (EMA) Parenteral Drug Association (PDA) News – EMA: Final Assessment Report on Nitrosamines, 22 […]
Medical Device Regulations & Regulatory Surveillance Summary – June 2020
This regulatory surveillance summary highlights key global regulatory developments from June 2020, including updates to Medical Device Regulations, guidance documents, and compliance expectations. By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, June 2020 US FDA is publishing a […]