Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

June 27, 2022

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Final Guidance

June 2022

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).

Download the Final Guidance Document

Read the Federal Register Notice

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TAGS: ANDA CDER FDA North America IND Agency Alerts CBER FD&C Act Regulatory Sciences

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