FDA approves the use of Medtronics MiniMed 670G insulin delivery system in patients with Type 1 diabetes seven years of age and older.
Federal Register notice: FDA classifies the next-generation sequencing-based tumor profiling test into Class 2 (special controls).
FDA approves an Impel NeuroPharma IND for a Phase 3 clincial trial of INP104, a novel, dihydroergotamine intranasal product for treating acute migrain...
CBER releases a list of 15 guidances it plans to issue in 2018.
Federal Register notice: FDA makes available a draft guidance entitled Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Bi...
Federal Register notice: FDA announces an 8/8 Antimicrobial Drugs Advisory Committee meeting two review two Paratek Pharmaceuticals NDAs.
PhRMA and BIO ask FDA to clarify issues in advance of a Pediatric Oncology Subcommittee meeting.
FDA pulls for further consideration a draft guidance on statistical approaches to evaluate analytical similarity between a biosimilar and a reference ...