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Providing Regulatory Submissions to 2026

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The document provides guidance for the electronic submission of Investigational New Drug Applications (INDs) to the Center for Biologics Evaluation and Research (CBER) of the FDA. It outlines the purpose, general issues, and specific organizational requirements for submitting INDs in electronic format, including folder structures, file naming conventions, and necessary documentation. The guidance aims to facilitate efficient review processes by ensuring that submissions are well-organized and accessible.

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Click ‘Get Form’ to open the Providing Regulatory Submissions to document in our platform's editor.
Begin by filling out the cover letter section. Ensure you include a description of your submission and any relevant regulatory information.
Navigate to the Form FDA 1571 section. Upload the signed PDF file named XXXX_1571.pdf, where XXXX is your submission serial number.
Organize your main folder by creating subfolders for Administrative, Chemistry, Manufacturing and Control (CMC), Nonclinical Pharmacology and Toxicology (Pharmtox), Clinical, and Other. Place relevant documents in each respective folder.
Utilize bookmarks and hypertext links throughout your document for easy navigation. This includes linking the table of contents to specific sections within your submission.
Finally, review all entries for accuracy before submitting. Use our platform’s tools to ensure that all files are virus-free and properly formatted.

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Why are regulatory submissions important?

Regulatory submissions are essential for obtaining the necessary approvals to conduct clinical trials, bring a drug to market or make changes to a previously approved product.

What is an example of a regulatory filing?

Examples of regulatory filings include tax returns, annual reports, and securities disclosures.

What is a regulatory submission?

A regulatory submission is a series of documents sent by a drug company to a health authority as evidence of compliance, Koperniak says. Laws and regulations influence many aspects of the drug development process.

What is the regulatory submission pathway?

Submission pathways are regulatory processes laid out by the FDA for medical device manufacturers to ensure safety and efficacy before these devices hit the market.

What provide regulatory submissions for medical devices in electronic format?

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled Providing Regulatory Submissions for Medical Devices in Electronic FormatSubmissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act. Amendments to the Federal Food, Drug, and Cosmetic Act (

What does regulatory filing mean?

Regulatory filings are time-bound documents required for submission by your company to relevant regulatory authorities across jurisdictions.

What does regulatory submission mean?

What are Regulatory Submissions? A regulatory submission is a series of documents sent by a drug company to a health authority as evidence of compliance, Koperniak says. Laws and regulations influence many aspects of the drug development process.

How to do a regulatory submission?

The regulatory submissions process involves 5 main stages, being: Pre-submission. Application preparation. Submission review. Addressing deficiencies. Approval.

Providing Regulatory Submissions to 2026

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