US FDA lays out GDUFA II post-CRL procedures
Generic Drug User Fee Amendments (GDUFA) II was signed into law on August 18, and was accompanied by a letter committing the US Food and Drug Administration (FDA) to certain review goals and procedure after issuing a CRL for an abbreviated new drug application (ANDA).
Draft guidance issued Friday laid out these goals, and has given industry 60 days to comment.
“FDA has committed to providing a scheduled date for 90 percent of post-CRL meetings within 10 calendar days of receipt of a written request,” the Agency said in the document. “FDA has further committed to conducting 90 percent of post-CRL meetings held on an FDA-proposed date within 30 days of receipt of a written request.”
The guidance addresses meeting requests from the sponsors post-CRL and how best to do this, the procedures for the conduct of such meetings, the subsequent documentation, and what to do if there are disputes regarding the accuracy and sufficiency of the minutes of such a meeting.
“The ANDA applicant’s concerns will be taken under consideration by the review division and the office director if the office director was present at the meeting. If the minutes are deemed to accurately and sufficiently reflect the meeting discussion, the PM [project manager] will convey this decision to the ANDA applicant and the minutes will stand as the official documentation of the meeting.
“If, after discussions with the requester, FDA deems it necessary to effect a change to the official minutes, the changes will be documented in an addendum to the official minutes.”
Choosing a submission
The FDA has also released draft guidelines on how to determine whether a generic drugmaker should submit an ANDA or a 505 (b)(2) application – both abbreviated pathways added as part of Hatch-Waxman Amendments to the FD&C Act in 1984.
The Agency says a drugmaker developing a product intended to have the same active ingredient, conditions of use, route of administration, dosage form, strength, and (with certain permissible differences) labeling as a reference listed drug (RLD) “may submit controlled correspondence to or request a pre-ANDA meeting with the Office of Generic Drugs (OGD),” to help determine the right pathway.
Once again, industry has 60 days to submit comments and suggestions regarding this draft document.
NDAs and ANDAs can be divided into the following four categories:
(1) A “stand-alone NDA” is an application submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act that contains full reports of investigations of safety and effectiveness that were conducted by or for the applicant or for which the applicant has a right of reference or use
(2) A 505(b)(2) application is an NDA submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use
(3) An ANDA is an application for a duplicate of a previously approved drug product that was submitted and approved under section 505(j) of the FD&C Act. An ANDA relies on FDA’s finding that the previously approved drug product, i.e., the reference listed drug (RLD), is safe and effective. An ANDA generally must contain information to show that the proposed generic product (1) is the same as the RLD with respect to the active ingredient(s), conditions of use, route of administration, dosage form, strength, and labeling (with certain permissible differences) and (2) is bioequivalent to the RLD. An ANDA may not be submitted if studies are necessary to establish the safety and effectiveness of the proposed product
(4) A petitioned ANDA is a type of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient) and for which FDA has determined, in response to a petition submitted under section 505(j)(2)(C) of the FD&C Act (suitability petition), that studies are not necessary to establish the safety and effectiveness of the proposed drug product
