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U.S. Department of Health and Human Services

For Industry

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U.S. Food and Drug Administration Statement: The impact of Hurricane Sandy on Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) deadlines

Due to the extreme weather conditions, federal government offices in the Washington, DC, metropolitan area, including those of the U.S. Food and Drug Administration (FDA), were closed October 29 and 30, 2012. 

Due to these closures, the FDA has put procedures in place to manage Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA) and Medical Device User Fee Act (MDUFA) goals that came due during, or are coming due soon after, these office closures. These procedures apply to all PDUFA, BsUFA and MDUFA goals. 
 
PDUFA goals include those related to the review of Investigational New Drug applications (IND), New Drug Applications (NDA), Biologics License Applications (BLA), and supplemental applications to NDAs and BLAs.  
 
BsUFA goals include those related to the review of INDs, and BLAs and supplemental application to BLAs submitted under 351(k) of the Public Health Service Act.
 
MDUFA goals include the review of Pre-market Approval (PMA) Applications, PMA Panel Track Supplements, 180-day PMA Supplements, Real-Time PMA Supplements, PMA Modules, and Pre-market Notifications (510(k)s). Investigational Device Exemptions are subject to statutory goals rather than MDUFA goals, but the same process will apply. 
 
  • PDUFA, BsUFA, and MDUFA goals that came due on October 29, 2012 or October 30, 2012:  As needed, the FDA will extend the PDUFA, BsUFA, and MDUFA goals for up to two business days.
 
For PDUFA, BsUFA, and MDUFA goals that are coming due October 31, 2012, and beyond, the FDA will assess the practicality of meeting the goal and will extend the goal as needed, but no more than the number of business days that the federal government and FDA buildings were closed.
 
The FDA does not anticipate the need to extend PDUFA, BsUFA and MDUFA goals for all applications currently under review.  We anticipate that many applications, particularly those with PDUFA, BsUFA and MDUFA goals further in the future, will not require an extension. The FDA intends to take regulatory action on pending applications in a timely manner; however, in some cases, extra time as described above, may be necessary for a full and thorough review of all drug and medical devices applications.
 
Furthermore, certain submissions that were sent to or were attempted to be delivered to FDA and would have normally been received during the closure may present issues regarding calculation of applicable review or regulatory clocks.  The effective receipt date may depend on the type of submission (e.g., electronic versus paper submissions) and when the FDA center to which the submission was sent resumed its document receiving services, among other factors.  Sponsors who have questions about specific submissions that they filed or attempted to file on October 29 or 30 should contact the review division or office responsible for the submission at issue.
 
Regulated industry should direct any further questions to their designated FDA point of contact.  Individual centers will provide additional updates to this statement as needed.