Docket Number:
FDA-2020-D-0420
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1). These recommendations pertain to the format of content contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) submitted to the Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER).

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All written comments should be identified with this document's docket number: FDA-2020-D-0420.