FDA will take a second look at bisphenol A in containers, said Commissioner Peggy Hamburg at a House Energy and Commerce Health Subcommittee hearing June 3. Committee Chairman Henry Waxman, D-Calif., asked Hamburg June 2 to reconsider the "possible dangers" of BPA at current exposure levels. He questioned FDA's conclusion under the Bush administration that BPA is safe and urged Hamburg to scrutinize FDA's reliance on industry studies (1"The Tan Sheet" Aug. 25, 2008, In Brief). FDA is reevaluating another Bush era move - its 2006 decision to restrict sales of OTC emergency contraceptive Plan B (2"The Tan Sheet" April 27, 2009, p. 6)
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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.’
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
