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This draft guidance provides information to generic drug sponsors on submitting prior approval supplements (PAS) under the Generic Drug User Fee Amendments (GDUFA). It outlines GDUFA performance metrics for reviewing PAS submissions within 6 or 10 months depending on whether an inspection is needed. The guidance describes procedures that can impact the review timeline, such as refusing submissions, amendments, inspections, grouped supplements, and incorrect reporting categories. It is intended to help sponsors comply with GDUFA requirements for PAS submissions starting in fiscal year 2015.
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ANDA Submissions – Prior Approval Supplements Under GDUFA
Título original
ANDA Submissions – Prior Approval Supplements Under GDUFA
This draft guidance provides information to generic drug sponsors on submitting prior approval supplements (PAS) under the Generic Drug User Fee Amendments (GDUFA). It outlines GDUFA performance metrics for reviewing PAS submissions within 6 or 10 months depending on whether an inspection is needed. The guidance describes procedures that can impact the review timeline, such as refusing submissions, amendments, inspections, grouped supplements, and incorrect reporting categories. It is intended to help sponsors comply with GDUFA requirements for PAS submissions starting in fiscal year 2015.
This draft guidance provides information to generic drug sponsors on submitting prior approval supplements (PAS) under the Generic Drug User Fee Amendments (GDUFA). It outlines GDUFA performance metrics for reviewing PAS submissions within 6 or 10 months depending on whether an inspection is needed. The guidance describes procedures that can impact the review timeline, such as refusing submissions, amendments, inspections, grouped supplements, and incorrect reporting categories. It is intended to help sponsors comply with GDUFA requirements for PAS submissions starting in fiscal year 2015.
Overview: Draft Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA
Background GDUFA Goals GDUFA is designed to bring greater predictability and timeliness to the review of generic drug applications by enabling FDA to assess user fees to fund critical and measurable improvements to FDAs generic drug program.
In the Commitment Letter that accompanied the legislation, FDA has committed to review and act on a certain percentage of prior approval supplements (PAS) within a specified time period from the date of submission for receipts starting in Fiscal Year 2015 (which begins on October 1, 2014).
The deadlines for review depend on whether a PAS requires an inspection.
Audience and Scope Guidance is narrowly tailored: Guidance is for sponsors of abbreviated new drug applications (ANDAs) preparing to file a prior approval supplement (PAS) on or after October 1, 2014.
Guidance does not apply to an amendment to a PAS if the PAS is submitted prior to October 1, 2014, even if the amendment is submitted on or after October 1, 2014.
Guidance does not apply to new drug applications (NDAs) or biologics license applications (BLAs).
Guidance does not apply to supplements filed for NDAs or BLAs, nor does it apply to changes-being effected (CBE) supplements or annual report filings for NDAs, BLAs, and ANDAs.
Purpose of the Guidance Describes how the GDUFA performance metric goals apply in the context of the PAS process.
Explains how various procedures applicable to a PAS may impact the performance goal date. Refuse-to-Receive Standards Inspections Amendments Grouped Supplements/Incorrect Reporting Category
GDUFA Performance Metrics Performance Metric Goals for PASs:
Inspection not needed 6 month goal Inspection needed 10 month goal Review and Act on 60% of PAS submissions in FY 2015 75% of PAS submissions in FY 2016 90% of PAS submissions in FY 2017
GDUFA Performance Metrics Calculating Goal Dates The submission date is the first day of the review period.
We calculate the goal date in months.
For example, if a complete PAS that does not require an inspection is submitted on November 3, 2014, its 6-month GDUFA goal date for review and action by the Agency is May 2, 2015.
We will provide the applicant with notice of the GDUFA goal date.
Filing an amendment to a PAS can revise the goal date associated with that PAS.
Procedures Impacting the GDUFA Goal Date RTR Standards
If FDA refuses to receive a PAS, the GDUFA review clock stops.
The applicant can submit a correct or new prior approval supplement but it will require a new GDUFA user fee.
Upon satisfaction of all applicable user fee obligations, we will issue correspondence indicating the adjusted receipt date, which results in a new GDUFA goal date for that PAS.
Procedures Impacting the GDUFA Goal Date Inspections Describes how the Agencys inspection process is applied in determining the GDUFA goal date for a PAS.
Explains that whether an inspection is required for a PAS is within the discretion of the Agency and will depend on the nature of the supplement.
Explains that in some circumstances it will be clear that an inspection is required and a 10-month goal date will apply. But, in many cases a PAS will not require an inspection and will have a 6-month goal date. There may also be some circumstances in which the goal date may change if it is later determined that an actual inspection is required, or not required. We will provide notice to the applicant if such a change occurs.
Explains that FDA will continue the practice of using a risk-based assessment in determining the need for an inspection. Procedures Impacting the GDUFA Goal Date Amendments to a PAS The Agency encourages applicants to submit supplements that are complete and ready for review, and to minimize the need for modifications to such supplements.
If an amendment is made to a PAS, the GDUFA goal date associated with that PAS may be revised.
This draft guidance briefly describes the amendment tiers outlined in the Commitment Letter, but directs the reader to the Agencys companion draft guidance for industry , ANDA Submissions Amendments and Easily Correctable Deficiencies Under GDUFA being issued concurrently with this guidance for more information on amendments made under GDUFA.
Procedures Impacting the GDUFA Goal Date Amendments to a PAS Example of how an amendment to a PAS can have an impact on the GDUFA goal date for that PAS: If a Tier 1 major amendment with a 10-month metric is submitted on 2/1/16 in response to a complete response letter for a PAS, this establishes a new GDUFA goal date of 10 months from the date of submission of the major amendment for that PAS. The new goal date is 11/30/16. If an amendment is made to a PAS prior to agency action on the PAS, it may adjust the GDUFA goal date for that PAS. For example: A PAS with a 6-month metric was submitted on 1/8/15 and given a goal date of 7/7/15. A Tier 1 delaying amendment with a 3-month metric is submitted in month 5 of the original review cycle on 5/19/15. Submission of the amendment adjusts the GDUFA review clock and extends the goal date 3 months from 5/19/15, the date of submission of the amendment for that PAS. The new goal date is 8/18/15.
Procedures Impacting the GDUFA Goal Date Other Matters Grouped Supplements Each PAS in a group of supplements is treated as its own individual submission and therefore would require a GDUFA PAS fee for each ANDA identified in the group. If the grouped submission includes only one fee, then only the lead submission will be received. This deficiency may result in different GDUFA goal dates for the lead supplement and subsequently filed supplements. ANDA sponsors have the option to submit a PAS with a comparability protocol that may result in a PAS required for the initial submission, with a reduced reporting category (e.g., CBE-30) for future reporting changes covered by the approved comparability protocol. The GDUFA performance metrics and user fees would apply to the initial PAS, but not to the future supplements submitted under the reduced reporting category.
Procedures Impacting the GDUFA Goal Date Other Matters Incorrect Reporting Category
The draft guidance explains that if the agency finds that a supplement submitted as a CBE should have been submitted as a PAS, it will notify the applicant explaining that the applicants submission is not accepted as a CBE supplement.
The applicant may resubmit the supplement as a PAS for FDA approval. The GDUFA performance metric goals and applicable user fees will apply to that PAS. The GDUFA review clock will start from the date of submission of that PAS.
Implementation This guidance is being issued in July 2014 to provide industry with information relevant to PAS submissions under GDUFA prior to the FY2015 start date.
This is a draft guidance and industry will have an opportunity for notice and comment (60 days).
Please submit any comments on the guidance to the public docket: FDA-2014-D-0901
Electronic comments may be submitted at www.regulations.gov.