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Federal Register notice: FDA reopens the comment period on a draft guidance entitled Real-World Data: Assessing Electronic Health ...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled CMC Postapproval Manufacturing Changes for Specified Biolog...[ Price : $8.95]
FDA posts a draft guidance entitled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions.[ Price : $8.95]
CDRH releases a discussion paper, 3D Printing Medical Devices at the Point of Care, that proposes potential point-of-care manufact...[ Price : $8.95]
FDA posts an International Council for Harmonization guidance entitled Q3C(R8) Impurities: Guidance for Residual Solvents.[ Price : $8.95]
Medtronics Covidien unit recalls its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly error.[ Price : $8.95]
FDA issues a draft guidance with recommendations for developing drugs or biological products to treat chronic rhinosinusitis with ...