Human Drugs
Clinical Pharmacology Considerations for Antibody-Drug Conjugates
FDA posts a draft guidance on antibody-drug conjugate clinical pharmacology considerations.
Human Drugs
FDAs Pazdur Red Flags China-based Oncology Programs
Writing in the 2/4 The Lancet, FDA Oncology Center of Excellence director Richard Pazdur calls into question the development of dozens of oncology dru...
GAO Report Looks at Unannounced Foreign Inspections
A just-released Government Accountability Office report offers recommendations on an FDA-planned pilot program to test unannounced foreign inspections...
Federal Register
Comments Extended on Device Discontinuance Notice
Federal Register notice: FDA extends the comment period for a 1/11 notice about a draft guidance entitled Notifying the Food and Drug Administration o...
Federal Register
Guide on OTC Drug Monograph Formal Meetings
Federal Register notice: FDA posts a draft guidance on over-the-counter monograph drug formal meetings between the agency and sponsors.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/4/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 2/04/2022.
Medical Devices
FDA Warning on E25Bio Covid Tests
FDA issues a warning to not use the E25Bio Covid-19 Direct Antigen Rapid Test due to concerns about false results.
FDA Green Lights Domestic Inspections Beginning 2/7
FDA removes its domestic inspection pause and will resume conducting inspections in the U.S beginning 2/7 now that Covid-19 cases are dramatically dec...
