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FDA publishes a guidance recommending principles for use in pivotal clinical studies to demonstrate the safety and effectiveness o...[ Price : $8.95]
Kazia Therapeutics says it will meet with FDA about a potential accelerated approval pathway for its glioblastoma drug paxalisib f...[ Price : $8.95]
Federal Register notice: FDA announces an 8/6 public workshop entitled Artificial Intelligence (AI) in Drug & Biological Product D...[ Price : $8.95]
Federal Register: FDA schedules an 8/2 advisory committee meeting to discuss a Zevra Denmark A/S NDA for arimoclomol, indicated fo...[ Price : $8.95]
FDA clears ImmersiveTouchs ImmersiveAR virtual and augmented reality operating room platform.[ Price : $8.95]
CBER issues a standard operating policy and procedure staff guide on administrative processing and review management procedures fo...[ Price : $8.95]
AdvaMedDx calls for two substantive changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic dev...[ Price : $8.95]
FDA grants PharmasstX an orphan drug designation for epigallocatechin gallate, a green tea extract for treating inflammatory bowel...