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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Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.
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Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.
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The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.