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- FDA issues final guidance on formal meeting types and timelines for drug and biologics sponsorsThe U.S. Food and Drug Administration released final guidance on August 13 that details the types of formal meetings sponsors can request during the development of new drugs and biologics. The doc…
- FDA releases weekly update on user fee letters and new HHS regulatory agendaThe FDA's latest weekly briefing highlighted the release of user fee commitment letters, which outline the agency's financial planning for upcoming fiscal periods. It also introduced a new regulat…