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Pharmaceuticals / Submissions and Approvals

FDA Explains How Amendments May Affect PDUFA Timelines

Sept. 3, 2014

The FDA has shed light on how amendments to an NDA, BLA or supplement may affect review timelines established under the 2012 prescription drug user fee program.

When any amendment to an application is received, the regulatory project manager (RPM), CDER division director and cross-discipline team leader first will determine whether it qualifies as a major amendment that requires a formal staff review, according to a new internal staff Manual of Policy and Procedures (MAPP) released last week.

If a review of the amendment is initiated, the FDA will then determine whether it will affect the deadline goal for making a decision on the product, said the document, which replaces a 2008 MAPP to reflect the PDUFA V review timelines established in the 2012 FDA Safety and Innovation Act. 

Under the reauthorized user fee program, CDER agreed to notify applicants of planned review timelines for new NDAs, BLAs and supplements. If the amendment extends the review timeline, then the RPM will notify the sponsor of the change and PDUFA goal date, the FDA said.

In rare cases, a major amendment may not extend the PDUFA date, but it could affect the review timeline. The RPM, team leader and division director must decide whether the original timeline will be retained or if a new one is needed, the FDA said. The RPM is responsible with notifying the applicant of any changes to the review timeline and that the PDUFA goal date is unchanged.
Minor amendments won’t affect the timeline.

The MAPP also notes that RPMs must notify the sponsor via a letter if serious problems with the application prevent discussion of labeling or postmarketing requirements or commitments.
The MAPP is available at www.fdanews.com/ext/resources/files/08/8-26-14-ReviewMAPP.pdf. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.