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FDA releases the FDA-483 with 10 observations from an inspection at Indias Shilpa Medicare Limited.[ Price : $8.95]
FDA issues a guidance on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription syste...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension request for Data To Support Drug Product Communicati...[ Price : $8.95]
The American Hospital Association urges FDA to take steps to reduce the regulatory burden on hospitals involving compounded drugs ...[ Price : $8.95]
Four drug stakeholders ask FDA to revise its draft guidance on REMS format and content.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Refuse to File: NDA and BLA Submissions to CDER.[ Price : $8.95]
Tremeau Pharmaceuticals says it has recently reached agreement with FDA on the development requirements to support an NDA for TRM-...[ Price : $8.95]
Federal Register notice: FDA establishes a Susceptibility Test Interpretive Criteria Web site that is intended to help efficiently...