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...
Former Decision Diagnostics CEO Keith Berman (Westlake Village, CA) pleads guilty to securities fraud, wire fraud, and obstruction of an official proc...
FDA tells isotretinoin manufacturers that they must modify their iPLEDGE Risk Evaluation and Mitigation Strategy to minimize the burden on patients, p...
