Procter & Gamble efficacy data on the UVA radiation protection potential of avobenzone in combination with zinc oxide or phenylbenzimidazole sulfonic acid are not adequate to support the combos addition to the sunscreen monograph, FDA tells the company in an April 8 letter. The agency gives the firm 30 days to provide additional data, after which it will make a decision based on extant information.
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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.’
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
