FDA guidance on content and format of ANDAs and associated webinar
FDA published a notice in the Federal Register announcing the availability of a draft guidance for industry, entitled ANDA Submissions--Content and Format of Abbreviated New Drug Applications.
FDA is issuing this 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 The draft guidance provides comprehensive assistance for the early stages of the application process so that an original ANDA will contain all information necessary for FDA to complete its review.
A pre-recorded webinar explaining this guidance is available at https://collaboration.fda.gov/p6kfmalydi8/
Submit electronic comments on the draft guidance to http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4886.