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Harvard Medical School researchers find FDA follows advisory committee recommendations 88% of the time, but is relying less on the...[ Price : $8.95]
FDA releases the form FDA-483 issued following a June inspection at Indias Ipca Laboratories.[ Price : $8.95]
FDA cites safety concerns in a complete response letter to Amneal Pharmaceuticals for its new formulation of Parkinsons drug carbi...[ Price : $8.95]
CDER publishes a Manual of Policies and Procedures on the operation of its site selection process for routine inspections.[ Price : $8.95]
FDA Webview posts the Federal Register notices published during our 7/3-10 annual Independence Day break.[ Price : $8.95]
CDRH says it is transitioning from paper export documents for medical devices to electronic export documents starting 1/2/2024.[ Price : $8.95]
FDA approves a labeling update for Novartis Leqvio (inclisiran) to allow earlier use in patients with elevated LDL-C who have an i...