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.’
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
