FDA Explains Timetable and Procedure for Electronic Submissions

The FDA has released the timetable and regulatory plan for its electronic submission requirements as well as the procedure for certain electronic submissions under section 745(a) of the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 379k–1). The FDA made the information available through two finalized guidances, one (79 FR 75570) explaining which types of submissions must be made electronically, when they must be submitted, and how the FDA will implement specific requirements related to electronic submission, and another (79 FR 75568) establishing standards for electronic data submission.

Electronic Submission

Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 355), the FDA is authorized to require electronic submission of certain content that sponsors and applicants submit to the agency. The FDA determined that because the specific electronic formats and submission types were too numerous to be contained in a single document, the agency decided to implement Section 745(a) through a series of guidances. At least 24 months after the FDA issues a final guidance specifying a type of information requiring electronic submission, the content must be submitted to the FDA electronically. The FDA plans to  “periodically issue guidances specifying the electronic format for types of submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs).”

Process

The procedural guidance sets out the FDA’s interpretation of the scope of Section 745(a) as well as waivers and exemptions that will apply to certain submission types. Additionally, the guidance sets out a timetable explaining the FDA’s plan for implementing the electronic submission requirements. In addition to requiring that INDs, ANDAs, BLAs, and NDAs be electronically submitted, Section 745(a) also requires that amendments, supplements, and reports related to those submissions must be electronically submitted as well. The guidance indicates that while only noncommercial INDs are currently exempt from the electronic submission requirements, the FDA may discuss additional exemptions in individual guidances for specific submissions. Similarly, the FDA plans to discuss the criteria for waivers in the upcoming individual guidances for specific submissions.

Specific Requirements

The FDA indicates that “individual draft guidances will be developed to specify the electronic formats, subject matter, and scope of applicability for submissions under Section 745A(a). Those draft guidances will be published in the Federal Register and subject to a comment period. After review and revision, the final version of the guidance will be published and will indicate the “date on which the new electronic submission formats specified in the guidance will be required for the submission types identified in the guidance document.” The guidance provides examples to help explain to sponsors and applicants how the FDA plans to interpret the timing and implementation of the new formats.

Study Data

The other final guidance released by the FDA details the specifics of electronic submission requirements for study data contained in NDAs, ANDAs, BLAs, and INDs. The FDA indicates that study data must be submitted in a form that the FDA can process, review and archive. Accordingly, the guidance indicates that submissions of clinical and nonclinical study data should use the standards specified in the Data Standards Catalog. The FDA may refuse to file or accept submissions that do not conform to the standards specified in the Data Standards Catalog. However, according to the guidance, the FDA may grant a waiver to allow sponsors or applicants an exception from using specific versions of FDA-supported standards. The FDA guidance sets out the specific email request procedure for obtaining such a waiver.

Timetable

The study data guidance also sets out exceptions to the general rule requiring studies beginning 24 months after the publication date to use FDA-supported standards. The agency indicates that updates to standards and new standards will result in the establishment of transition dates or dates when sponsors and applicants will be expected to abide by the new or revised standards in their submissions.

Authority

Additionally, the FDA made clear in both guidances that due to the authority granted to the FDA through Section 745(a), the guidances the agency issues under the section are binding and establish legally enforceable responsibilities. Congress granted “explicit authorization” to the FDA to implement the statutory electronic submission requirements of Section 745(a) in guidance form. As a result, the FDA guidances carry considerably greater authority than typical suggestive FDA guidance documents and use the imperative language “must or required” when describing the obligations of sponsors and applicants.