For Industry

Contact eSubmitter

For your convenience, we have set up an email account so we can answer your questions about the eSubmitter software. Please send your questions or comments related to the eSubmitter Application to the eSubmitter Technical Support Team at: esubmitter@fda.hhs.gov.

(If you are looking to submit a general question or comment please find the appropriate email address listed at FDA Basics for Industry: Submit Questions and Comments.)

Send questions about FDA regulations or template specific questions to the specific program office listed below. Please be sure to include your name, company name and contact information in the email.

Center Email Phone
CBER - OBRR regulatory questions CBER_eSubmitter_program@fda.hhs.gov or your Consumer Safety Officer  
CBER-ICSR questions CBERICSRSUBMISSIONS@fda.hhs.gov  
CDER - Drug Registration and Listing questions edrls@fda.hhs.gov  
CDER - Adverse Event Reporting questions FAERSESUB@fda.hhs.gov   
CDER - Generic Drug Facility Electronic Self-Identification CDEReFacility@fda.hhs.gov  
CDRH - eCopies For eCopy technical questions, contact cdrhesub@fda.hhs.gov.
For eCopy regulatory questions, contact CDRH-eCopyinfo@fda.hhs.gov.
For eSubmitter questions, contact eSubmitter@fda.hhs.gov.
 
CDRH - eMDR regulatory questions eMDR@fda.hhs.gov  
CDRH - ISO 13485 questions ISO13485@fda.hhs.gov  
CDRH - In Vitro Devices and Radiological Health For regulatory questions, contact the Division of Industry and Consumer Education (DICE) at dice@cdrh.fda.gov.
For technical questions, contact cdrhesub@fda.hhs.gov.
1-800-638-2041
CTP - Guidances or the Tobacco Control Act questions TobaccoIndustryQuestions@fda.hhs.gov 1-877-CTP-1373
CVM - ONADE Regulatory Support
Technical Support
 

Page Last Updated: 07/23/2015
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