FDA Draft Guidance for Industry: Content and Format of Abbreviated New Drug Applications
FDA published a notice in the Federal Register announcing the availability of a draft guidance for industry, entitled ANDA Submissions–Content and Format of Abbreviated New Drug Applications.
On July 9, 2012, the Generic Drug User Fee Amendments (GDUFA) was signed into law by the President to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. Under GDUFA, FDA agreed to certain obligations as laid out in the GDUFA Commitment Letter. Among these obligations is FDA’s commitment to performance metrics for the review of original ANDAs. For example, FDA has committed to review and act on 90 percent of original ANDA submissions within 10 months from the date of submission in Year 5 of the program, which begins on October 1, 2016.
In an effort to increase the number of original ANDAs that the Agency can receive upon initial submission and to decrease the number of review cycles required to approve an application for marketing, FDA prepared this guidance on improving the quality of original ANDA submissions. FDA is committed to providing comprehensive assistance in the early stages of the application process to ensure that an original ANDA contains all information necessary for FDA to complete its review in one review cycle.
This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on “ANDA Submissions—Content and Format of Abbreviated New Drug Applications.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Submit electronic comments on the draft guidance to http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4886.