GDUFA II to review 90% of priority submissions in 8 months

The FDA intends to review 90% of priority review ANDAs deemed complete within 8 months, according to the agency’s GDUFA II commitment letter. The letter, issued on 14th October, could also result in faster approvals and ways to resolve the backlog of ANDAs, for example, by the agency determining whether to receive an ANDA within 60 days of its submission and allocating goal dates to all ANDAs.

The new priority review for generic applications within 8 months will require the Sponsor to submit complete Pre-Submission Facility Correspondence two months prior to the date of ANDA submission. If the Applicant does not submit any Pre-Submission Facility Correspondence, the review will be within 10 months. The review classification could be changed from a standard to priority review by FDA, in which case the applicant will be notified by FDA says within 14 days of the date of the change. Faster reviews are also proposed for ANDA amendments. Quicker reviews of standard ANDAs are promised, but it remains to be seen whether this comes to fruition.

FDA pledges to review and respond to 90% of standard controlled correspondence within 60 days of the date of submission, and review and respond to complex controlled correspondence within 120 days of submission. In terms of information requests (IRs) and discipline review letters (DRLs), FDA says it will issue the appropriate ones from each review discipline as soon as the review is completed.

FDA will grant or decline most (90%) of Product Development Meeting requests within 30 days of receipt of the request in 2018 and 2019. From 2020, 2021 and 2022, a timeline of 14 days from receipt of the request is proposed.

In terms of setting forth procedures for filing reviewers on communication of minor technical deficiencies (e.g., document legibility) and on deficiencies potentially resolved with information in the ANDA at original submission, FDA says it will issue a MAPP by 1 October 2017 in order to provide applicants with an opportunity for resolution within 7 calendar days.

FDA intends to put forward procedures for filing reviewers on minor technical issues and issues that can be resolved with information in the ANDA at original submission. There will be an opportunity to fix such issues within 7 calendar days so they will not be a basis for a refuse-to-receive decision.

FDA plans to issue product-specific guidance identifying the methodology for developing drugs and generating evidence needed to support ANDA approval, for 90% of new chemical entity NDAs that are approved on or after 1 October 2017, at least two years prior to the earliest ANDA filing date.

Comments on this draft goals letter can be submitted until 7 November 2016.