FDA released "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)". It sets forth revisions to the 2021 3 rd revision ...
FDA posted a draft guidance for comment today "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection" This one is pretty ...
Thank you, @TinaMorris, for this fantastic update on AAPS activities and the science community. It has been a great pleasure working with AAPS and ...
Dear AAPS members – As we head toward the end of Q1, I can feel the creative energy crackling for all our meetings this year! The call for programming ...
The FDA Published Draft Guidance on 3-Year New Clinical Investigation Exclusivity FDA has released a new draft guidance for industry, "New Clinical ...