FDA Review posts product approval summaries for the week ending 12/10/2021.
Federal Register notice: FDA reopens the comment period on a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical ...
Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs.
Federal Register notice: FDA makes available a final guidance entitled CMC Postapproval Manufacturing Changes for Specified Biological Products to Be ...
FDA posts a draft guidance entitled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions.
CDRH releases a discussion paper, 3D Printing Medical Devices at the Point of Care, that proposes potential point-of-care manufacturing scenarios for ...
FDA posts an International Council for Harmonization guidance entitled Q3C(R8) Impurities: Guidance for Residual Solvents.