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FDA posts a draft guidance entitled Benefit-Risk Considerations for Product Quality Assessments, which describes the agencys benef...[ Price : $8.95]
The International Medical Device Regulators Forum (IMDRF), of which FDA is a member, seeks comments on a proposed guidance entitle...[ Price : $8.95]
CBER director Peter Marks tells a House briefing that FDA is not delaying its review of Modernas Covid-19 vaccine for children und...[ Price : $8.95]
FDA lifts a clinical hold on LogicBio Therapeutics Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with me...[ Price : $8.95]
Federal Register notice: FDA announces that it is withdrawing approval of Bristol Myers Squibbs (Celgene) peripheral T-cell lympho...[ Price : $8.95]
Federal Register notice: FDA announces a 6/8 Pharmacy Compounding Advisory Committee meeting to discuss four bulk drug substances ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and En...[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Testosterone.