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FDA 2024: Watch For Trial-Diversity Guidance, Final Quality Systems Rewrite

 
• By Elizabeth Orr

Industry observers at RAPS Convergence in Montreal last week said the FDA’s agenda for 2024 is likely to include increased emphasis on MDUFA goals, enhanced cybersecurity requirements, the new QMSR, and more. 

People in business attire peep through binoculars behind the word 2024.
• Source: Shutterstock

Watch for the US Food and Drug Administration to act on a trial diversity guidance, enhanced device cybersecurity, the revised quality systems regulations, and more in 2024, two industry observers said at the Regulatory Affairs Professionals Society (RAPS) Convergence meeting in Montreal.

The 4 October session was led by Alexander Gaffney, executive director of regulatory policy and intelligence at Politico’s AgencyIQ, and...

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