The DC Circuit Court of Appeals rules against FDA in a suit challenging the agencys denial of orphan drug exclusivity for Eagles Bendeka.
Two drug trade associations suggest ways FDA could improve a draft question-and-answer guidance on pediatric study plans for oncology drugs.
Ropes & Gray analyzes a federal court decision that could force companies to submit 10 years worth of clinical trial results to Clinical Trials.gov th...
Federal Register notice: FDA makes available a draft guidance entitled Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.
Attorney Steven Boranian says a Louisiana federal court decision to dismiss state law claims against a gadolinium contrast manufacturer due to federal...
Federal Register notice: FDA debars Jagen Lewicki for five years from importing or offering for import any drug into the U.S.
Federal Register notice: FDA debars Matthew Dailey for 10 years from importing or offering for import any drug into the U.S.
President Trump says he has asked FDA to cut through red tape and reduce regulatory barriers, presumably to advance products associated with the coron...