FDA publishes a draft guidance with clinical pharmacology considerations to assist industry in developing peptide drug products.
CDER Office of Clinical Pharmacology policy lead Qin Sun uses a podcast to explain the agencys risk-based approach to evaluating drug-drug interaction...
Federal Register notice: CDER and CBER announce that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Stud...
Attorney Allyson Mullen sees the potential for chaos if FDA tries to implement its proposed rule on laboratory-developed tests without adequate resour...
More than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement to obtain better dosing (optimal dose) informa...
FDA approves a ReShape Lifesciences PMA supplement for the companys next-generation Lap-Band 2.0 FLEX, an implant indicated for weight reduction in pa...
FDA accepts for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with non-erosive gastroes...
FDA issues a revised final guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling an...
