viernes, 19 de febrero de 2010
U.S. Food and Drug Administration Statement: The impact of February’s inclement weather on Prescription Drug User Fee Act (PDUFA) and Medical Device..
U.S. Food and Drug Administration Statement: The impact of February’s inclement weather on Prescription Drug User Fee Act (PDUFA) 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 from February 8, 2010, to February 11, 2010. In addition, the building at FDA’s White Oak campus that houses most of the new drug review staff for FDA’s Center for Drug Evaluation and Research (CDER) as well as the CDER document room was closed for an additional day on Friday, February 12, 2010, due to emergency building maintenance.
Due to these closures, the FDA has put procedures in place to manage Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) goals that came due during, or are coming due soon after, the closure of its offices. These procedures apply to all PDUFA 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. MDUFA goals include the review of Premarket Approval (PMA) applications, PMA Panel Track Supplements, 180-day PMA Supplements, Real-Time PMA Supplements, PMA Modules, and Premarket Notifications (510(k)s).
PDUFA and MDUFA goals that came due during the week of February 8, 2010, or are coming due the week of February 15, 2010: As needed, the FDA will extend the PDUFA goals for up to 5 business days and MDUFA goals for up to 4 business days.
For PDUFA and MDUFA goals that are coming due February 22, 2010, 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 that PDUFA and MDUFA goals for all applications currently under review will be extended. We anticipate that many applications, particularly those with PDUFA and MDUFA goals further in the future, will not require an extension. FDA plans to work to ensure that regulatory actions on pending applications are taken in a timely manner; however, in some cases it may be necessary to take the extra time described above to ensure that all drug and medical device applications receive a full and thorough review.
Furthermore, all submissions that were sent to FDA and would have normally been received during the closure may not be marked as “received”, for purposes of calculating any review or regulatory clocks, until the FDA center to which the submission was sent resumes its document receiving services. Time to resumption of activity may vary from center to center or based on type of submission (e.g., electronic versus paper submissions).
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.