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Regulatory Agency Submissions

Regulatory agency submissions can be made in both paper and electronic formats. Electronic submissions can be made by providing your electronic files on physical media (e.g., CD-ROM or DVD) and transmitting these physical media by means such as mail or a courier service or by using the FDA Electronic Submission Gateway (ESG). The FDA ESG is an agency-wide portal mechanism for receiving submissions in electronic format which enables the secure submission of regulatory information for review. Regardless of the format, attention to detail and compliance with current guidance greatly improves the chances of submission approval/acceptance on the first try.

WHO SHOULD DO FDA REGULATORY AGENCY SUBMISSIONS?

Industry Examples of Required Regulatory Agency Submissions
Pharmaceutical New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (IND), Biologics License Application (BLA), Drug Master File (DMF), Biologics Master File (BMF), Structured Product Labeling (SPL) for Electronic Drug Listing
Medical Device 510(k) (Premarket Notification), PMA (Premarket Approval), De Novo (Evaluation of Automatic Class III Designation), HDE (Humanitarian Device Exemption)
Dietary Supplement Premarket New Dietary Ingredient Notification (NDIN), Food Facility Registration, Prior Notice of Imported Foods

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