The US Food and Drug Administration (FDA) has issued draft guidance, ANDA Submissions—Content and Format of Abbreviated New Drug Applications, which is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to the FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)). The draft guidance details the information to be provided in each section of the Common Technical Document (CTD) format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by the FDA to assist in preparing the submission. The guidance does not address the fee structure or payment of obligations under the Generic Drug User Fee Amendments (GDUFA) and does not address the submission and assessment of drug master files, amendments to original ANDAs, and changes being effected or prior approval supplements.
GDUFA was signed into law on July 9, 2012 to speed the delivery generic drugs to the public and reduce costs to industry. Under GDUFA, FDA agreed to meet certain obligations as laid out in the GDUFA Commitment Letter. Among these obligations is the FDA’s commitment to performance metrics for the review of new ANDAs that are submitted electronically following the electronic CTD (eCTD) format. For example, the FDA has committed to review and act on 90% of original ANDA submissions within 10 months from the date of submission in Year Five of the program, which begins on October 1, 2016.
To meet these performance goals, FDA is issuing the draft guidance to assist ANDA applicants in improving the quality of submissions, to increase the number of original ANDAs acknowledged for receipt upon initial submission, and to decrease the number of review cycles. The FDA said it is committed to providing comprehensive assistance in the early stages of the application process, so that an original ANDA will contain all information necessary for FDA to complete its review in one review cycle.
The draft guidance identifies the information an applicant should include to ensure that a complete, high-quality application is submitted to FDA. FDA has previously published guidance on the filing process, including the refuse-to-receive standards, which should be reviewed thoroughly to avoid common deficiencies found in ANDA submissions.