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Federal Register Notice: FDA announces an opportunity to request a hearing on a proposal to withdraw approval of 14 NDAs.[ Price : $8.95]
FDA says a Baylis Medical recall of its TorFlex transseptal guiding sheath kits is Class 1.[ Price : $8.95]
CDRH issues a guidance on considerations for study design in medical device pivotal studies.[ Price : $8.95]
FDA places on partial clinical hold a Curis Phase 1 clinical trial of its oral inhibitor of apoptosis antagonist, CUDC-427 due to ...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on bioequivalence recommendations for iron sucrose.[ Price : $8.95]
Federal Register Notice: FDA releases additional draft and revised draft product-specific bioequivalence recommendations to suppor...[ Price : $8.95]
Federal Register Notice: CDRH announces the Web site location for proposed fiscal year 2014 guidance documents.[ Price : $8.95]
FDA approves a W. L. Gore PMA for its 25 cm Gore Viabahn Endoprosthesis with Heparin Bioactive Surface for treating symptomatic pe...