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FDA publishes an International Council for Harmonization question-and-answer guidance on the M9 guidance on biopharmaceutics class...[ Price : $8.95]
Federal Register notice: FDA announces a 6/8 Antimicrobial Drugs Advisory Committee meeting to discuss an AstraZeneca BLA for nirs...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Current Good Manufacturing Practice in Manu...[ Price : $8.95]
FDA leaves a five-item Form FDA-483 after a 2/27-3/7 inspection of Rentschler Biopharmas manufacturing facility in Baden-Wurttembe...[ Price : $8.95]
Rejected by FDA for accelerated approval, Lilly says it will seek the fastest traditional approval possible for its donanemab to t...[ Price : $8.95]
FDA approves a GlaxoSmithKline BLA for Arexvy (respiratory syncytial virus vaccine, adjuvanted), for preventing lower respiratory ...[ Price : $8.95]
FDA publishes the International Council for Harmonization Q9(R1) foundational quality risk management guidance.[ Price : $8.95]
Federal Register notice: FDA corrects a 4/24 notice entitled Advancing the Utilization and Supporting the Implementation of Innova...