For Industry

U.S. Food and Drug Administration Statement: The impact of the December 5, 2018 Government Closure on PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, and AGDUFA goal dates and IND deadlines

Federal agencies will be closed on December 5, 2018 in honor of the 41st President of the United States, George H. W. Bush.

Due to this closure, the FDA has put procedures in place to manage Prescription Drug User Fee Amendments (PDUFA), Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Amendments (BsUFA) Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Amendments (ADUFA), and Animal Generic Drug User Fee Amendments (AGDUFA) goal dates that fall on December 5th, or shortly thereafter. These procedures apply to all PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, and AGDUFA goals described in the relevant commitment letters.

PDUFA goals include those related to the review of Investigational New Drug applications (IND), New Drug Applications (NDA), Biologics License Applications (BLA) submitted under section 351(a) of the Public Health Service Act, and supplemental applications to NDAs and BLAs. 

GDUFA goals include those related to the review of Abbreviated New Drug Applications (ANDAs) and supplemental applications to ANDAs.

BsUFA goals include those related to the review of INDs, and BLAs and supplemental application to BLAs submitted under section 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, De Novo requests, Pre-market Notifications (510(k)s), Pre-Submissions, CLIA waiver by applications, and Dual 510(k) CLIA waiver by applications.

ADUFA goals include those related to the review of Investigational New Animal Drug (INAD) files, New Animal Drug Applications (NADA), and supplemental applications to NADAs.

AGDUFA goals include those related to the review of Generic Investigational New Animal Drug (JINAD) files, Abbreviated New Animal Drug Applications (ANADA), and supplemental applications to ANADAs.

Additionally, INDs for human drugs are subject to statutory timeframes for review; as described below, FDA will apply the same procedures to these IND deadlines as to user fee goal dates.

PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, and AGDUFA goal dates and IND review deadlines that fall on December 5, 2018 – December 7, 2018:

FDA will extend the PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, and AGDUFA goal dates and the IND review clocks for up to one business day.

FDA does not anticipate the need to extend these timeframes for all applications currently under review.  For example, we anticipate that many applications, particularly those with goals further in the future, will not require an extension.  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 drug and device applications.

In addition, certain submissions that are sent or attempted to be delivered to FDA for receipt on December 5th may present issues regarding calculation of applicable review or regulatory clocks.  The effective receipt date may depend on the kind of submission (e.g., electronic versus paper submissions) and when the FDA center to which the submission was sent can resume its document receiving services, among other factors.  Sponsors who have questions about specific submissions that they filed or attempted to file on December 5, 2018 should contact the review division or office responsible for review of 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.

Page Last Updated: 12/04/2018
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