CBER Medical Deputy Director David Feigal, MD, is named CDRH director. He will assume his duties during a one-month transition period. A replacement for his post at the Center for Biologics Evaluation & Research has not been named. Feigel joined FDA in 1992 as head of the Division of Antiviral Drug Products in the Center for Drug Evaluation & Research. He assumed his current position in the biologics center in September 1997
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
