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FDA issues a draft guidance leveraging its experience in implementing the MDUFA 3 Dual 5120(k) and CLIA Waiver by Application path...[ Price : $8.95]
FDA warns South Koreas Dae Young Foods Company about CGMP and misbranding violations in its work as a contractor manufacturing fin...[ Price : $8.95]
CDER Office of Surveillance and Epidemiology deputy director Robert Ball describes the ways in which the agencys Sentinel System i...[ Price : $8.95]
A Public Citizen analysis of 457 rulemakings withdrawn by the Trump administration finds that 26 were from FDA, the highest number...[ Price : $8.95]
FDA posts a draft guidance on Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Wai...[ Price : $8.95]
Two Hyman, Phelps attorneys say FDA is helping generic drug applicants by starting to list patent submission dates in the Orange B...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Pediatric Information for X-ray Imaging Device Premarket Notifica...[ Price : $8.95]
Commissioner Scott Gottlieb says FDA ramps up its efforts to improve the process for developing generic copies of complex drugs.