Procter & Gamble submits additional UVA efficacy data supporting the addition of avobenzone combined with either 2-pherrylbenzimidazole-5 sulfonic acid (PBSA) or zinc oxide in the final sunscreen monograph. The in vivo data show 1.5% PBSA with 3% avobenzone had a protection factor of 3.6, versus 1.4 for PBSA alone. Similarly, 4% zinc oxide combined with 3% avobenzone had a 5.6 protection factor compared to 2.3 with zinc oxide alone. P&G originally submitted safety data on the ingredients after a Jan. 27 "feedback" meeting with the agency ("The Tan Sheet" March 15, In Brief). FDA found the data insufficient ("The Tan Sheet" April 26, p. 9)
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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.’
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
