FDA issues a draft guidance with information for sponsors and nonclinical laboratory staff about the management and conduct of pathology peer review p...
FDA issues a draft guidance on testing and labeling medical devices for safety in the magnetic resonance environment.
FDA issues a final guidance on developing drugs to treat bacterial vaginosis.
Federal Register notice: FDA makes available a draft guidance entitled E8(R1) General Considerations for Clinical Studies.
FDA extends for five years its medical device innovation collaboration with Frances Dassault Systmes.
FDA expands the approval for Leo Pharmas Enstilar and Taclonex to treat plaque psoriasis in patients 12 years and older.
Ultragenyx Pharmaceutical files an NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders.
CDERs Office of Prescription Drug Promotion says a CooperSurgical TV spot for ParaGard is misleading because it doesnt give risk information.