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Latest News

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31 July 2020
Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) last week reached a consensus on endpoints that would be acceptable as primary endpoints in randomized controlled trials for therapeutics to treat ...
31 July 2020
The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities.
31 July 2020
This update includes new information on dexamethasone, RLF-100, Actemra, lenzilumab, convalescent plasma, Pepcid, TXA127, LAM-002A and DNL758.
30 July 2020
Four new bulk substances are up for inclusion on the list of active pharmaceutical ingredients that outsourcing facilities can use in drug compounding under section 503B of the Federal Food, Drug, and Cosmetic Act , according to a proposal from t...
30 July 2020
This update includes new information on vaccine candidates from Moderna, Pfizer/BioNTech, Heat Biologics, Gamaleya Research Institute and Covaxin. 
30 July 2020
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.