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FDA publishes a draft guidance with clinical pharmacology considerations to assist industry in developing peptide drug products.[ Price : $8.95]
CDER Office of Clinical Pharmacology policy lead Qin Sun uses a podcast to explain the agencys risk-based approach to evaluating d...[ Price : $8.95]
Federal Register notice: CDER and CBER announce that support begins for version 2.0 of the Clinical Data Interchange Standards Con...[ Price : $8.95]
Attorney Allyson Mullen sees the potential for chaos if FDA tries to implement its proposed rule on laboratory-developed tests wit...[ Price : $8.95]
More than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement to obtain better dosing (o...[ Price : $8.95]
FDA approves a ReShape Lifesciences PMA supplement for the companys next-generation Lap-Band 2.0 FLEX, an implant indicated for we...[ Price : $8.95]
MAPS Public Benefit Corp. files what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine ca...[ Price : $8.95]
FDA accepts for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with ...