Associate Director William Fairweather, PhD, departs after 25 years in FDA's Center for Drug Evaluation and Research. The office was reorganized with the creation of the Office of Post-marketing Drug Risk Assessment in October. Fairweather moves on to serve as president of Flower Valley Consulting, a Maryland-based statistics/data management consulting firm of which he is the founder. Division of Biometrics IV Acting Director Mohammed Huque, PhD, also from the former Office of Epidemiology and Biostatistics, has been named director of the Division of Biometrics III in the new Office of Biostatistics
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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.’
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
