Federal Register notice: FDA makes available a draft guidance entitled Refuse to File: NDA and BLA Submissions to CDER.
Tremeau Pharmaceuticals says it has recently reached agreement with FDA on the development requirements to support an NDA for TRM-201 (rofecoxib), whi...
Federal Register notice: FDA establishes a Susceptibility Test Interpretive Criteria Web site that is intended to help efficiently update such criteri...
FDA approves a Boston Scientific PMA for the Vercise Deep Brain Stimulation System and its use for treating symptoms of Parkinsons disease.
The Medical Information Working Group says there are instances in which industrys regulatory burden could be eased through additional regulation rathe...
Federal Register notice: FDA determines that Mercks Noroxin (norfloxacin) tablets, 400 mg, was not withdrawn due to safety or effectiveness concerns.
FDA asks the Office of Management and Budget to review its proposal for two studies determining how well consumers and healthcare professionals can sp...
FDA warns Koreas Seindni Company about CGMP and labeling violations in its manufacturing of finished drug products.