MDIC says FDA is joining its new Pathology Innovation Collaborative Community.
Federal Register notice: FDA makes available a final guidance entitled Safer Technologies Program for Medical Devices.
Federal Register notice: FDA makes available a draft guidance entitled Human Gene Therapy for Neurodegenerative Diseases.
Teva raises concerns with an FDA compliance policy on bioavailability and bioequivalence samples to be retained.
Stakeholders recommend ways to improve the effectiveness of FDAs proposed posting of REMS summaries.
FDA grants priority review to AstraZenecas Farxiga to treat patients with chronic kidney disease with and without Type 2 diabetes.
Former CDER director Janet Woodcock, who has been on detail at the White Houses Operation Warp Speed, moves to the Office of Commissioner to serve as ...
Federal Register notice: FDA withdraws a 12/29 Federal Register notice entitled Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fi...