Points of Contact for Questions Regarding Registration and Listing for Human and Animal Drugs and Biologics
Listed below are the FDA points of contact for the different types of questions that industry or the general public often have about registration and listing for human and animal drugs and biologics:
For questions re: Technical assistance with ESG Gateway account
Technical inquiries regarding opening a new Gateway account should be directed to the ESG Gateway Helpdesk.
For ESG technical support requests and other Questions/concerns: firstname.lastname@example.org
- How long does it take to open a new Gateway account?
- What should I submit in my Letter of Non-Repudiation?
- How do I obtain an x.509 Digital Certificate?
For questions re: Technical assistance with the SPL
Technical help questions and inquiries regarding the SPL should be directed to the SPL Coordinator in the Office of the Commissioner, Office of Critical Path Programs (OCPP).
- Why did I get an error message with my submission? What does it mean?
- What are the validation procedures?
- How do I send product labels for my listing?
For questions re: Firm registration status
Questions regarding a firms’ registration status.
- I registered for the current year but DECRS still shows my last year registration.
- Why my firm appears twice in DECRS?
- I submitted my registration SPL with the correct spelling of the firm’s name but it’s wrong in DECRS. How did it happen? Can you fix it?
For questions re: Drug listing status
Questions regarding drug listing status should be directed to the appropriate Center.
Listing status inquiries regarding the NDC Directory
should be directed to CDER's Office of Compliance, Drug Registration and Listing team. Contact the eDRLS Team at email@example.com
- When does my product appear in the NDC Directory?
- I submitted a listing but my product has not been published in the Directory.
- Listing status for API products.
For questions re: Regulatory questions or request for general information
Questions regarding general registration and listing information or 21 CFR Part 207 should be directed to the appropriate Center.
Registration and listing for DRUG products
Registration and listing for VETERINARY products
Registration and listing for BIOLOGIC products
- Do I need to list?
- Do I need to register?
- Do I need a labeler code?