GDUFA II: Requests for Reconsideration

Transcription

1 GDUFA II: Requests for Reconsideration Priya Shah, Pharm.D. Immediate Office Project Manager Office of Regulatory Operations, Office of Generic Drugs

2 Purpose To provide an overview of requests for reconsideration under GDUFA II with a focus on industry impact 2

3 Commitment Letter Language II. Original ANDA Review Program Enhancements C. Review Classification Changes During the Review Cycle 6. If an applicant requests a teleconference as part of its request to reclassify a major amendment or standard review status, FDA will schedule and conduct the teleconference and decide 90% of such reclassification requests within 30 days of the date of FDA s receipt of the request for a teleconference. This goal only applies when applicant accepts the first scheduled teleconference date offered by FDA. 3

4 Commitment Letter Language II. Original ANDA Review Program Enhancements E. Dispute Resolution 1. An applicant may pursue a request for reconsideration within the review discipline at the Division level or original signatory authority, as needed. 2. The OGD Office of Regulatory Operations Associate Director will track each request for Division level reconsideration through resolution. 4

5 Commitment Letter Language II. Original ANDA Review Program Enhancements E. Dispute Resolution 3. Following resolution of a request for reconsideration, an applicant may pursue formal dispute resolution above the Division level, pursuant to procedures set forth in the September 2015 Guidance, Formal Dispute Resolution: Appeals Above the Division Level. 4. FDA will respond to appeals above the Division level within 30 calendar days of CDER s receipt of the written appeal pursuant to the applicable goal. a. In FY 2018, the goal is 70 percent. b. In FY 2019, the goal is 80 percent. c. In FY 2020, 2021, and 2022 the goal is 90 percent. 5. CDER s Formal Dispute Resolution Project Manager (or designee) will track each formal appeal above the Division level through resolution 5

6 Working Group Organization Center for Drug Evaluation and Research Office of Generic Drugs Office of New Drugs Office of Pharmaceutical Quality Office of Regulatory Operations Office of Generic Drug Policy Office of Bioequivalence Office of Research and Standards Office of Process and Facilities Office of Lifecycle Drug Products Office of Policy for Pharmaceutical Quality Office of Program and Regulatory Operations 6

7 What is New/Changed? GDUFA II Performance Goals Guidance for Industry Standardized Process for Requests for Reconsideration 7

8 GDUFA II Performance Goals Schedule, conduct teleconference, and decide 90% of reclassification requests of a major amendment or standard review status within 30 days of receipt* of the request Respond to appeals above the Division level within 30 calendar days of CDER s receipt of the written appeal In FY 2018, the goal is 70 percent. In FY 2019, the goal is 80 percent. In FY 2020, 2021, and 2022 the goal is 90 percent. *received by the FDA via the Electronic Submissions Gateway (ESG) 8

9 Guidance for Industry 9

10 Guidance for Industry Outlines considerations for applicants before submitting a request for reconsideration Matters that are not appropriate for a request for reconsideration will not be accepted for review A request for reconsideration that includes new information will not be accepted for review Outlines timelines and procedures for submitting and responding to a request for reconsideration Written request via Electronic Submissions Gateway Cover letter identifies submission as a Request for Reconsideration 10

11 Process for Requests for Reconsideration ANDA applicant submits request for reconsideration via ESG Project Manager conducts a preliminary review of the request to evaluate whether the request should be accepted If request is accepted, original signatory authority will evaluate and send a written decision to the applicant 11

12 Who is Responsible? Applicant Project Manager Original Signatory Authority Associate Director of Operations 12

13 Applicant Responsibilities ANDA applicant submits request for reconsideration via ESG Submits request for reconsideration to the ANDA file Should not submit a request for a matter that is not appropriate for this process Should not include new information in the request FDA encourages the applicant to submit the request according to the draft guidance Submit courtesy copies to the appropriate individuals Submit within 7 calendar days from the date of the regulatory action Identify the request as a Request for Reconsideration on the cover letter 13

14 Project Manager Responsibilities Project Manager Project Manager conducts a preliminary conducts a review of the request to preliminary review evaluate whether the of the request to request should be evaluate whether accepted the request should be accepted If request is not accepted for review Inform the applicant on behalf of the signatory authority Identify the reason why the request was not accepted If request is accepted for review Forward the request to the signatory authority Send the applicant an acknowledgement letter identifying the signatory authority including the GDUFA goal date, if applicable including the date of the teleconference, if applicable 14

15 Original Signatory Authority Responsibilities Project Manager If Project conducts request Manager is a accepted, preliminary review original conducts of signatory a the request to authority preliminary review evaluate will whether evaluate the and of the request to request send a should written be evaluate decision whether accepted to the request applicant should be accepted Review the request once it has been deemed accepted for review May consult with subject matter experts regarding the matter under reconsideration Provide the applicant with a final written decision either granting or denying the request *the original signatory authority may delegate their request for reconsideration to another deciding official* 15

16 Associate Director of Operations Responsibilities Track each request for division level reconsideration through resolution Serve as the administrative contact for the FDA and industry for all procedural related issues regarding reconsideration requests ANDA applicant submits request for reconsideration via ESG Project Manager conducts a preliminary review of the request to evaluate whether the request should be accepted If request is accepted, original signatory authority will evaluate and send a written decision to the applicant 16

17 What should Industry expect? Predictable timelines for responses to requests for reconsideration Receipt of Not Accepted letters for requests that contain new information or that are not appropriate for this process Teleconferences to discuss the issue(s), but not opportunities to seek a decision from FDA 17

18 What can Industry do to assist? Send courtesy copy to appropriate individuals identified in the draft guidance Submit within 7 calendar days from the date of the regulatory action Identify the request as a Request for Reconsideration on the cover letter 18

19 Tips for Industry Do not submit requests for matters that are not appropriate for this process, including, but not limited to: Information requests and discipline review letters General advice letters and advice communicated during meetings or teleconferences Meeting minutes Do not submit new information as part of the request Do not submit for reclassification of a Major amendment to an easily correctable deficiency, information requests, or discipline review letter The review cycle has been closed by FDA by taking the action of issuing the complete response letter 19

20 Resources GDUFA II Commitment Letter: GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years Draft Guidance for Industry: Requests for Reconsideration at the Division Level Under GDUFA Draft Guidance for Industry and Review Staff: Formal Dispute Resolution: Appeals Above the Division Level 20

21 External Contact Inquiries related to specific requests: contact the project manager Inquiries related to the process: contact the Associate Director of Operations at 21

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