Friday 13 December 2019

GDUFA II Goals For ANDA Reviews




GUDFA –II Goals for ANDA Reviews

 


The GDUFA II (fiscal years 2018-2022) commitment letter describes a consolidated review scheme for all cohorts of abbreviated new drug applications (ANDAs).USFDA targets to review ANDA applications as detailed below. 

Submission Type
Goal
Original ANDAs
Standard Original ANDAs
90% within 10 months of submission date.
Priority Original ANDAs
Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j)
Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and
The information remains unchanged relative to the date of the submission of the application
Within 10 months of submission date if:
The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria.
The applicant does not pre-submit facility information, or the facility information changes or is found to be incomplete or inaccurate.
ANDA Amendments
Standard Major ANDA Amendments
Within 8 months of submission date if preapproval inspection not required.
Within 10 months of submission date if preapproval inspection required.
Priority Major ANDA Amendments
Within 6 months of submission date if preapproval inspection not required.
Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j)
Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and
  • The information remains unchanged relative to the date of the submission of the application
Within 10 months of submission date if:
  • The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria.
  • When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.

Standard and Priority Minor ANDA Amendments
Within 3 months of submission date.
Prior Approval Supplements
Standard PASs
Within 6 months of submission date if preapproval inspection not required.
Within 10 months of submission date if preapproval inspection required.
Priority PASs
Within 4 months of submission date if preapproval inspection not required.
Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j)
  • Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and
  • The information remains unchanged relative to the date of the submission of the application.
Within 10 months of submission date if:
  • The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria.
  • When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.
Prior Approval Supplements Amendments 
Standard PAS Major Amendments
Within 6 months of submission date if preapproval inspection not required.
Within 10 months of submission date if preapproval inspection required.
Priority PAS Amendments


Within 4 months of submission date if preapproval inspection not required.
Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j)
  • Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and
  • The information remains unchanged relative to the date of the submission of the application.
Within 10 months of submission date if:
  • The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria.
  • When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.

Standard and Priority Minor PAS Amendments
Within 3 months of submission date.

Criteria for Priority Review

1. Submissions containing certain patent certifications and exclusivity statements
  • Submissions for drug products for which there are not more than three approved drug products listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) and for which there are no blocking patents or exclusivities listed for the reference listed drug (RLD) may receive a priority review.
  • Submissions that contain a paragraph IV certification but become eligible for approval during the review period as a result of no blocking patents or exclusivities (including 180-day exclusivity under section 505(j)(5)(B) of the FD&C Act (180-day exclusivity)) and no applicable stays may receive a priority review if no other generic version of the same RLD has been brought to market under an approved ANDA. The absence of any blocking patent, exclusivity period, or stay must be appropriately documented in order for a priority review to be granted. For 180-day exclusivity, “no exclusivity” means that the 180-day exclusivity has either been relinquished or waived or that FDA has determined that a forfeiture of the exclusivity has occurred.
  • Submissions that contain a paragraph IV certification, are submitted on the first day that any valid paragraph IV application for the drug in question is submitted, and are received as substantially complete (i.e., submissions that have “first filer” status) may receive a priority review.
  • Submissions for drug products blocked by 180-day exclusivity that have been tentatively approved or submissions for drug products blocked by 180-day exclusivity that OGD determines will likely be ready for approval upon or shortly after expiration of the 180-day exclusivity may receive a priority review when such exclusivity is triggered.
2. Submissions related to drug shortages
Submissions that could help mitigate or resolve a drug shortage and prevent future shortages, including submissions related to products that are listed on FDA’s Current Drug Shortages Index at the time of the submission, may receive a priority review.

3. Submissions that are subject to special review programs such as the President’s Emergency Plan for AIDS Relief
Submissions in this category may receive a priority review.

4. Submissions related to public health emergencies
Submissions that either could help address a public health emergency declared by the Secretary of the U.S. Department of Health and Human Services, or anticipated under the same criteria as apply to such a declaration, may receive a priority review.

5. Submissions related to certain government purchasing programs
 Submissions related to certain government purchasing or procurement activities, including expiration-date extensions or packaging changes usually requested by the Government-Wide Quality Assurance Program, may receive a priority review.

6. Submissions subject to statutory mandates or other legal requirements
Submissions that are subject to federal or state mandates or other legal or regulatory actions may receive a priority review as necessary to comply with those requirements. Note: This category includes legally required changes in formulation or labeling. However, supplements submitted following actions taken by FDA field staff against applicants who put changes into effect that are required to have approved supplements under 21 CFR 314.70 will not be considered for a priority review.

7. Supplements for which a priority review is requested under 21 CFR 314.70(b)
Under 21 CFR 314.70(b), an applicant may ask FDA to grant a priority review to “a supplement for public health reasons or if a delay in making the change described in [the supplement] would impose an extraordinary hardship on the applicant.” For priority reviews, “extraordinary hardship on the applicant” will be interpreted to include the following:
i.             Catastrophic events such as explosion, fire, or storm damage to manufacturing facilities.
ii.            Events that could not have been reasonably foreseen by the applicant and for which the applicant could not have planned. Examples include:
1. An abrupt discontinuation of the supply of an active ingredient, packaging material, or container closure system.
2. The relocation of a facility or a change in an existing facility because of a catastrophic event. (In the absence of a catastrophic event, the applicant should contact OGD early in the planning stage of a contemplated relocation or change.)

8. Submissions for “sole source” drug products
 Submissions for drug products for which there is only one approved drug product listed in the Prescription Drug Product List (i.e., the “active section”) of the Orange Book and for which there are no blocking patents or exclusivities may receive a priority review, except when the approved drug product was approved pursuant to a suitability petition under section 505(j)( C) of the FD&C Act.

If approval of a submission either is dependent on the expiration of a patent (i.e., the submission contains a paragraph III certification) or is dependent on the expiration of an exclusivity period, OGD and OPQ will seek to complete the review of the submission in a manner that would permit approval by the last applicable patent expiration date or exclusivity date. However, with regard to ANDAs submitted on or after October 1, 2014:
i.             ANDAs submitted within 1 year of the last applicable patent expiration date or exclusivity date will not be considered for priority review, and FDA can provide no assurances that the review will be completed in a manner that would permit approval by the last applicable patent expiration date or exclusivity date. However, this provision may be subject to an exception when it is determined that the submission should be granted a priority review to address a public health concern. These determinations will be made by the OGD regulatory project manager (RPM) and OGD management in consultation with other FDA personnel as necessary.
ii.            ANDAs submitted more than 30 months in advance of the last applicable patent expiration date or exclusivity date will not be considered for a priority review.

FDA will only consider a priority request when (1) the submission and cover letter clearly state “Priority Review Requested” and reference the ANDA number (when applicable), (2) the basis for the request is consistent with FDAs prioritization procedure, (3) the applicant clearly and briefly states the basis of the request, and (4) the applicant includes sufficient supporting documentation for the request.

DEFINITIONS

Expedited Review: FDA will strive to act on an ANDA as soon as possible, including prior to the goal date if possible. An expedited review, though, does not result in a shorter goal date.

Priority Review: FDA will either (1) give a shorter goal date or (2) grant an expedited review.

Shorter Goal Date: In accordance with the GDUFA II Commitment Letter, FDA commits to one of the following (1) for original ANDAs, an 8-month goal date; (2) for major amendments, a 6- or 8-month goal date; or (3) for prior approval supplements, a 4- or 8-month goal date.



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