Writing in PLOS online journal, three FDA researchers find a significant increase in the development of new tropical disease drugs after Congress enac...
FDA outlines its planned Complex Innovative Designs Pilot Meeting Program that is intended to advance the use of complex adaptive, Bayesian, and other...
Federal Register notice: FDA makes available a guidance entitled Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage F...
Federal Register notice: FDA determines that Prolixin (fluphenazine hydrochloride) tablets, 1 mg (mg), 2.5 mg, 5 mg, and 10 mg, were not withdrawn fro...
The American Society of Clinical Oncology and the Friends of Cancer Research jointly give FDA draft guidance language to expand eligibility for cancer...
FDA says it wants to do research on how well healthcare professionals and consumers can use direct-to-consumer print ad prescription drug disclosures ...
FDA extends to 9/24/19 the compliance date for submission requirements of a device constituent of co-packaged combination products assigned to CDER fo...
FDA announces a 9/10 public workshop entitled Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.