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.’
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
