FDA To Join The 'Real World' Under PDUFA VI
Under round six of the user fee agreement with industry, the FDA is pledging to explore the use of real-world evidence, strengthen the patient's voice in the drug review process and boost the agency's postmarketing surveillance abilities.
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Biopharma industry is preparing for the unwelcome possibility that the new Congress and Trump Administration will seek to revisit provisions in the negotiated agreement for the US FDA user fee program's reauthorization.
Agency reviewers believed the line between patient input and external intimidation had been crossed; early data from the Sarepta muscular dystrophy drug's flawed development program stoked patient community expectations and made regulatory review difficult.
The biopharmaceutical industry is hoping the terms set under the negotiations with the FDA for the sixth round of the Prescription Drug User Fee Act will help reduce the time and money spent on developing medicines, allowing companies to get their products into the commercial setting quicker and maximize those therapies' potential.