FDA Releases Draft Guidance on ANDA Submissions

FDA has released draft guidance on the content and format of abbreviated new drug applications (ANDAs) to assist in the preparation of ANDAs submitted to FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

The draft guidance outlines the requirements for each section of the Common Technical Document (CTD) format for product applications and identifies supporting guidance documents and recommendations issued by FDA to assist in preparing the submission. Information on what an applicant should include to ensure a complete, high-quality application is presented. Previously published guidance has been published by FDA on the filing process, including the refuse-to-receive standards.

The fee structure or payment of obligations under the Generic Drug User Fee Amendments (GDUFA), the submission and assessment of drug master files (DMFs), amendments to original ANDAs and changes being effected, or prior approval supplements are not addressed in the draft guidance.