This draft guidance discusses the requirements and implementation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding valid electronic submissions of manufacturing establishment information (MEI). Twenty-four months after this draft has been finalized, MEI contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and amendments, supplements, or resubmissions of these application types must be submitted electronically in the format specified in this guidance. This draft guidance also applies to drug master files that are submitted for incorporation by reference into an NDA, ANDA, or BLA.
For additional information on how FDA interprets and intends to implement the electronic submission requirements of section 745A(a) of the FD&C Act, please see the guidance for industry Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (745A Implementation Guidance).
In section 745A(a), Congress granted explicit authorization to FDA to specify, by guidance, the electronic format for submissions under section 505(b), (i), or (j) of the FD&C Act and submissions under section 351(a) or (k) of the Public Health Service Act (PHS Act), which include MEI. Accordingly, to the extent that this document provides such requirements under section 745A(a) of the FD&C Act, indicated by the use of the words must or required, this document is not subject to the usual restrictions in FDA’s good guidance practice (GGP)regulations, such as the requirement that guidances not establish legally enforceable responsibilities.
To comply with the GGP regulations and make sure that regulated entities and the public understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard language explaining that guidances should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. FDA is not including this standard language in this guidance because it is not an accurate description of this guidance. Insofar as this guidance specifies the format for electronic submissions pursuant to section 745A(a) of the FD&C Act, it will have binding effect.