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FDA issues a final guidance entitled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifi...[ Price : $8.95]
Federal Register notice: FDA announces an 11/1 joint advisory committee meeting to review an Alkermes NDA for major depressive dis...[ Price : $8.95]
FDA grants Pfizer a Breakthrough Therapy designation for its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482...[ Price : $8.95]
An analysis by the Alliance for a Stronger FDA says that the agencys fiscal year 2019 appropriations, which are part of a four-bil...[ Price : $8.95]
The FDA charges A & O Enterprises, a seller of intravenously injected therapy products (iV Cocktails), with making a range of dece...[ Price : $8.95]
FDA approves a Vita Medical PMA for the Recell Autologous Cell Harvesting Device for treating severe thermal burns in patients 18 ...[ Price : $8.95]
FDA grants MicuRx Pharmaceuticals fast track status and a qualified infectious disease product desgination for contezolid (MRX-I) ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Da...