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FDA posts a draft guidance entitled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions.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.
Medtronics Covidien unit recalls its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly error.
FDA issues a draft guidance with recommendations for developing drugs or biological products to treat chronic rhinosinusitis with nasal polyps.
FDA issues a guidance with recommendations for the development of pediatric anti-infective drug products.