The US Food and Drug Administration (FDA) on Friday published draft guidance that would establish a new type of letter the agency sends to generic drugmakers to provide applicants with preliminary thoughts on possible deficiencies of an abbreviated new drug application (ANDA).
Thanks to the recently reauthorized Generic Drug User Fee Amendments (GDUFA II), FDA will issue Deficiency Review Letters (DRLs) and information requests (IRs) to obtain further information or clarification to allow completion of a discipline review.
"The purpose behind IRs and DRLs is to improve FDA's predictability and transparency, promote the efficiency and effectiveness of FDA's review process, minimize the number of review cycles necessary for approval, increase FDA's overall rate of approval, and facilitate greater access to generic drug products," the draft says.
IRs and DRLs will be sent to ANDA applicants at "about the mid-point of the review clock," the draft guidance says, except "when a discipline review results in the ability to act on a received ANDA."
But the issuance of an IR or a DRL will generally not affect the review clock, FDA says, and an applicant's response generally will not be classified as a major or minor amendment.
A DRL will pertain to items that the review team believes may require resolution prior to full (or tentative) approval of the application, and the agency notes it will not issue a DRL if its issuance would delay or coincide with the issuance of a CRL.
"However, if a response to an IR or a DRL contains either gratuitous information not requested by FDA or information that requires a more thorough review as determined by FDA, FDA will classify the submission as an amendment and assign an appropriate new goal date for that amendment," the draft notes.
Deficiencies addressed by applicants in a response to an IR or a DRL may also appear in a CRL if FDA's review of the response has been deferred or if FDA has outstanding concerns, though FDA notes that if the applicant receives a CRL, but has responded to some (or all) identified deficiencies in an IR or DRL response, the applicant "does not need to re-submit previously submitted information in a CRL amendment. However, the applicant should still submit a CRL amendment and should clearly identify the previously provided IR or DRL response that renders its CRL amendment complete."
Information Requests and Discipline Review Letters Under GDUFA: Guidance for Industry