Gary Gamerman: The Jan. 22 issue of "The Pink Sheet" (p. 7) misattributed a speech on gene therapy regulation actually delivered by Fenwick & West attorney Gary Gamerman. Gamerman, who joined the Washington, D.C. office of the Palo Alto-based law firm in 1992 from Baker & Hostetler, was an IND reviewer for FDA's Center of Biologics Evaluation & Review from 1988 to 1990...
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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.’
Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.
Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.
Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.
