Agency rejects PhRMA requests to ease certification process and limit rule's application; separately, law firm Hyman, Phelps & McNamara objects to FDA practice of delaying ANDA approval announcements until it issues a petition decision.
FDA’s final rule on citizen petitions makes only minor revisions to its proposed regulation, most notably shortening the agency’s response time from 180 days to 150 days.
The document instead is largely devoted to rejecting suggestions by the Pharmaceutical Research and Manufacturers of America to alter the...
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
