Dear AAPS members – Spring is peeking around the corner! New life is starting to bud after what was a long, cold winter, especially for those in the ...
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FDA posted a draft guidance for comment today "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection" This one is pretty ...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 ...