While the center for drugs has enjoyed an influx of new reviewers in the last few years, the hiring frenzy has resulted in a significant shift in CDER's makeup: 38% of reviewers in the Office of New Drugs have less than two years of on-the-job experience. Office of New Drugs director John Jenkins discusses the challenges with training the new recruits, and how industry should adapt
By Kate Rawson
The last two fiscal years have seen great gains in the number of new employees hired in FDA's Center for...
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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.’
Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
