Jesse Goodman, FDA's new chief scientist and acting deputy commissioner, is in a pivotal role in the new Administration, as the bridge between the career staff at FDA and the incoming political leadership. His keynote address at the Food & Drug Law Institute Annual meeting is a must read for anyone looking for signs of how the Obama agenda will affect FDA.
By Michael McCaughan
This year was different.
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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.’
Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
