FDA says a guidance on conducting clinical trials during the Covid-19 pandemic takes effect immediately.
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Federal Register notice: FDA makes available a draft guidance entitled Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.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.