FDA has "tentatively concluded that [Parsol 1789] cannot be included in the [OTC sunscreen drug products] monograph at this time," Jeanne Rippere of FDA's Office of OTC Drug Evaluation told a Nov. 16 FDA Compliance Seminar in Washington, D.C. Although Rippere noted that the agency is still evaluating additional data, including data submitted by Givaudan-Roure ("The Tan Sheet" Sept. 26, p. 16), FDA "felt [it] needed to know more about Parsol and its interaction with other sunscreens with which it might be combined under the OTC monograph system." Explaining FDA's cautious approach to Parsol 1789, Rippere also cited "reports of increased incidence of sensitization from dibenzoylmethanes in Europe," "adverse drug experiences" and "recent problems" associated with Allergan Herbert's Photoplex, which the company withdrew from the U.S. last year due to marketing considerations
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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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order.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.”
