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FDA issues a Form 483 after it finishes a pre-license inspection of Abeonas Cleveland, OH manufacturing facility concerning the co...[ Price : $8.95]
FDA releases a draft guidance entitled Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.[ Price : $8.95]
Federal Register notice: FDA corrects a date in a 3/12 notice announcing the availability of a guidance entitled Early Alzheimers ...[ Price : $8.95]
FDA grants Biotronik a beakthrough device designation for the Freesolve below-the-knee resorbable magnesium scaffold, intended for...[ Price : $8.95]
GSK reports favorable overall survival and progression-free survival data in a Phase 3 trial involving Jemperli (dostarlimab) in a...[ Price : $8.95]
A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.s Telangana, India sterile drug manufacturing facility results in a seven...[ Price : $8.95]
Federal Register notice: FDA withdraws the approval of Bayers NDA for Aliqopa (copanlisib) in response to a failed confirmatory tr...[ Price : $8.95]
FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.