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FDA posts a draft guidance entitled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions.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.
Federal Register notice: FDA withdraws approval of a Fresenius Kabi NDA for Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection)...
Federal Register notice: FDA posts a draft guidance entitled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulato...