[ Price : $8.95]
FDA approves an Urotronic PMA for Optilume Urethral Drug Coated Balloon for use in male urethral strictures.[ Price : $8.95]
An FDA advisory committee votes 7 to 3 that a BrainsGate PMA for its Ischemic Stroke System did not demonstrate that the devices b...[ Price : $8.95]
Federal Register notice: FDA reopens the comment period on a draft guidance entitled Real-World Data: Assessing Electronic Health ...[ Price : $8.95]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FDA posts a draft guidance entitled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions.[ Price : $8.95]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.