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FDA To Join The 'Real World' Under PDUFA VI

 
• By Donna Young

Regulators pledge to explore the use of real-world evidence, strengthen the patient's voice in drug review, and boost the agency's postmarketing surveillance abilities as part of sixth round of user fee program with industry.

PDUFA VI letter

FDA has decided to join the real world next year – or at least, explore it, in terms of what type of data it will consider from innovator drug makers.

Under negotiations with the innovator biopharmaceutical community for the sixth round of the reauthorization of the Prescription Drug User Fee Act (PDUFA VI), which will run from fiscal years (FYs) 2018 through 2022, FDA has agreed to take a look at using real-world evidence in its decision-making processes, according to the agency's proposed

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