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The FDA has released a draft guidance, Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing (June 2026), with comments due by September 1, 2026. This draft guidance discusses the use of public and platform knowledge to support the development of gene ...

The FDA has released a draft guidance, Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products (May 2026), with comments due by July 30, 2026. This draft guidance aligns with FDA's efforts to reduce reliance on animal testing and outlines approaches for ...

The MHRA has released a draft guidance, The Rare Disease Therapies Regulatory Framework, for public consultation (released 21 May 2026; comments close 30 July 2026, 11:59 PM UK time). The consultation and full draft are here: https://www.gov.uk/government/consultations/draft-rare-disease-therapies-r ...

The MHRA has released a draft guidance, The Rare Disease Therapies Regulatory Framework, for public consultation (released 21 May 2026; comments close 30 July 2026, 11:59 PM UK time). The consultation and full draft are here: https://www.gov.uk/government/consultations/draft-rare-disease-therapies-r ...

Excited to see the Pharmaceutical Quality (PQ) Community officially getting started! 🎉 If you haven't seen the announcement yet, our first meeting is this Friday, May 29, 2026, from 2:00–2:55 PM EST - and it's shaping up to be a great kickoff. We'll be discussing the formation of two scientific ...

There is another opportunity for volunteers to be part of the Selection Committee for the Distinguished Pharmaceutical Scientist Award. The Selection Committee is required to include AAPS members with experience working in academia, industry, and regulatory to ensure the committee can fairly assess ...