Four Sidley Austin attorneys say FDA is planning to issue a notice of proposed rulemaking to assert its authority to regulate laboratory-developed tes...
FDA says SystImmune can start Phase 1 studies of its BL-B01D1 in some lung cancer patients.
Harvard Medical School researchers find FDA follows advisory committee recommendations 88% of the time, but is relying less on them.
FDA releases the form FDA-483 issued following a June inspection at Indias Ipca Laboratories.
FDA cites safety concerns in a complete response letter to Amneal Pharmaceuticals for its new formulation of Parkinsons drug carbidopa/levodopa.
CDER publishes a Manual of Policies and Procedures on the operation of its site selection process for routine inspections.
FDA Webview posts the Federal Register notices published during our 7/3-10 annual Independence Day break.
