The US Food and Drug Administration (FDA) has released draft guidance which establishes a new type of letter the agency sends to generic drug manufacturers to provide applicants with initial thoughts on possible deficiencies of an abbreviated new drug application (ANDA). The FDA will issue discipline review letters (DLRs) and information requests (IRs) to attain further information or clarification to ensure completion of a discipline review.
The guidance explains how the FDA will issue and use an IR and/or a DRL during the review of an original ANDA. The guidance does not apply to an amendment made in response to a Complete Response Letter (CRL), a supplement, or an amendment to a supplement.
The draft guidance states that “the purpose behind IRs and DRLs is to improve FDA’s predictability and transparency, promote the efficiency and effectiveness of FDA’s review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”.
ANDA applicants will receive IRs and DRLs at roughly the mid-point of the review clock, except when “a discipline review results in the ability to act on a received ANDA.” An applicant’s response generally will not be classified as a major or minor amendment.
The FDA states that if the applicant receives a CRL, but has responded to 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.”
To view the guidance regarding information requests and discipline review letters, please click here.