FDA proposes longer reviews for PDUFA V

FDA is proposing to add two months to the review period for new molecular entity (NME) NDAs and original BLAs according to minutes from a Nov. 18 meeting with industry to discuss reauthorization of PDUFA. FDA's proposal would start the six- and 10-month Priority and Standard reviews after the agency's two-month validation and filing period, rather than at the time of the application's submission. The agency said the additional time would allow for a "late phase" meeting with sponsors after primary and secondary reviews are complete to discuss issues identified by FDA reviewers, plan for advisory committee meetings and address potential risk management considerations.

FDA also proposed to submit its background package to sponsors 21 days ahead of an advisory committee meeting. Currently, FDA's briefing documents are available two business days prior to an advisory committee. All other non-NME and -original NDA and BLAs would be reviewed under the current procedure. ...