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MannKind Corp. Message Board

  • vcppaddler vcppaddler Oct 9, 2013 6:22 AM Flag

    FDA activities during the shutdown


    During the lapse period, FDA will not accept PDUFA applications or supplements that require payment of a fee (e.g., New Drug Applications (NDAs) or certain Biologics License Applications (BLAs)), unless the FY 2014 fee was paid prior to October 1, 2013. FDA expects to continue to review PDUFA applications and supplements for which all applicable user fees were received prior to October 1.
    For example, for an application or supplement that requires a fee, if the FY 2014 fee was received on September 30, 2013, FDA expects to review the application, even if the application or supplement itself is submitted during the lapse period.
    However, if an application or supplement was received on September 30, 2013 and the fee was received on October 1, then FDA will not review the submission, because it cannot accept the fee.
    During the lapse period, FDA will accept new regulatory submissions for which no fee is required, if the product is within the scope of the PDUFA program. These types of submissions include, for example:
    Investigational new drugs applications (INDs)
    Annual reports
    Supplements to NDAs and BLAs for which clinical data with respect to safety or effectiveness are not required for approval (this includes most manufacturing and labeling supplements)
    NDAs or BLAs that only have orphan designated indications, or a supplement for an orphan designated indication
    Submissions that fall within the exemption for previously filed applications or supplements
    Applications for which FDA has waived the application fee (e.g., small business waiver)
    General correspondence
    Sponsors who have not yet paid PDUFA product or establishment fees for FY 2014 should not remit payment during the lapse period, because FDA cannot accept the fees. Sponsors will not be in arrears for FY 2014 product or establishment fees during the lapse period. The due date for these fees will be the first busin

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