FDA’s proposed rule offers possible timeframes and solicits comments. Agency says 12 months after the final rule is issued would be the earliest date that manufacturers would be able to ramp up production to meet demand, and 2009 is the latest date that the international community would allow an exemption for ozone-depleting CFC inhalers.
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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.’
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
