Information Requests and Discipline Review Letters of US FDA

·         The Generic Drug User Fee Amendments of 2017 (GDUFA II) was signed into law on August 18, 2017 in order to facilitate timely access to high quality, affordable generic medicines.

 ·         As part of GDUFA II, FDA agreed to two program enhancements centered on improving communications during a review-cycle:

- Discipline Review Letters; and

- Information Requests.

 ·         The recently published draft guidance entitled Information Requests and Discipline Review Letters Under GDUFA, explains how the Agency intends to deploy these two program enhancements during the review of an original abbreviated new drug application (ANDA).

 

Discipline Review Letter (DRL)

Ø  Generally, a DRL will be issued from each discipline as it finishes its initial review of its portion of a received ANDA.

Ø  It will not represent a complete review of the entire submission and does not necessarily reflect input from all supervisory levels.

Ø  It allows applicants to know, as soon as possible, early thoughts on possible deficiencies within specific sections of an application.

 Information Request (IR)

 Ø  A DRL is intended to convey early thoughts on possible deficiencies found during a discipline review whereas an IR will request further information or clarification that is needed or would be helpful to proceed with the discipline review.

Ø  As with DRLs, an IR will not represent a complete review of the entire submission and will not necessarily reflect input from all supervisory levels.

IR/DRL Timing

 Ø  Generally, no later than about the mid-point of the GDUFA goal date: - Discipline reviews will be complete; and - IRs and/or DRLs will have been issued.

Ø  While DRLs may only be issued after the completion of a discipline review, IRs may be issued at any time.

 IR/DRL Responses

 Ø  DRLs and IRs may contain a requested response date; an applicant may request a short extension if they are unable to respond by a requested response date.

Ø  Responses to an IR or a DRL generally will not affect the review clock.

Ø  FDA will strive to review a response during the review cycle in which it is received if such review can be completed during such a review cycle.

Reference: https://www.fda.gov/media/109961/download