During the height of COVID it was not uncommon to hear top US Food and Drug Administration officials tell the public its role as a regulator of medical products is to “call the balls and strikes,” deflecting suggestions it operates with political ideology by saying it acts as a neutral arbiter of science.
Puberty Blocker Petition Raises Questions About When FDA Should Weigh In On Off-Label Drug Use
FDA is most often thought of as a regulator of off-label communication, but a new citizen petition on a contentious topic highlights the murkiness of the agency’s own obligations to discuss unapproved uses of drugs – particularly when effectiveness comes into play – and the challenges when medicine use becomes politically polarized.
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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.’
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.