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U.S. Department of Health and Human Services

Drugs

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Points of Contact for Drug Registration and Listing

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.
Questions/concerns relating to corporate/ personal email policy: esgprep@fda.hhs.gov
For ESG technical support requests: esgreg@gnsi.com
 
Examples: 
  • 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).
Contact the SPL Coordinator at spl@fda.hhs.gov
Examples:
  • 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 step by step instructions visit: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm177328.htm.
 
SPL and eDRLS instruction page: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm.
 

For questions re: Firm registration status

Questions regarding a firms’ registration status.
Contact the SPL Coordinator at spl@fda.hhs.gov.
In addition, to check a firm’s current registration, see the Drug Establishment Current Registration Site (DECRS) : http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm (this is a public website that is directly populated by registration SPLs).
 
Examples:
  • 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 for animal drugs can be found in the Electronic Animal Drug Product Listing Directory at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm191015.htm. Contact AskCVM@fda.hhs.gov or call 240-276-9300.
 
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 edrls@fda.hhs.gov
 
Examples:
  • 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.  
 
Contacts:
 
Registration and listing for DRUG products
Email eDRLS team at edrls@fda.hhs.gov or call 301-796-3130
 
Registration and listing for VETERINARY products
Email AskCVM@fda.hhs.gov or call 240-276-9300
 
Registration and listing for BIOLOGIC products
Email CBER CBERSPL@fda.hhs.gov  or call 301-827-0373
  
Examples:
  • Do I need to list?
  • Do I need to register?
  • Do I need a labeler code?