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: firstname.lastname@example.org.
(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.
|CBER - OBRR regulatory questions||CBER_eSubmitter_program@fda.hhs.gov or your Consumer Safety Officer|
|CDER - Drug Registration and Listing email@example.com|
|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 firstname.lastname@example.org.
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 email@example.com.
For technical questions, contact firstname.lastname@example.org.
|CTP - Guidances or the Tobacco Control Act questions||TobaccoIndustryQuestions@fda.hhs.gov||1-877-CTP-1373|
|CVM - ONADE||Regulatory Support