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CVM eSubmitter Resource Center

CVM eSubmitter Resources

FDA Electronic Submissions Gateway (ESG) Resources

Additional Training Resources Related to ADUFA and AGDUFA Reauthorization

On August 14, 2018, President Trump signed the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, reauthorizing the U.S. Food and Drug Administration’s user fee programs for pioneer and generic new animal drugs. These changes take effect October 1, 2018. FDA developed several training resources to help drug sponsors understand the recent changes to the submission process.  Additional Information can be found on the New Animal Drug Application Training Resources page.

CVM eSubmitter Webinar Series Resources

Webinar 1 - FDA ESG and CVM ESS Registration Process

Webinar 2 - How to Use the eSubmitter Tool

(Note: Recordings below were made on 8/22/2018, templates updates may have occurred after the time of the recordings. View the eSubmitter History page for a summary of changes.)

Animal Bioengineering and Cellular Therapies (ABCT) Team

Template Recording Duration Transcripts
I-A-OT 10 min. Transcript
V-A-OT (Type VII) 15 min. Transcript
Tech Section Intro 4 min. Transcript
I-P-DP 11 min. Transcript
I-P-PC 25 min. Transcript

Chemistry, Manufacturing and Controls 1

Template Recording Duration Transcripts
INAD-P-MC 1 hr. 4 min. 55 sec. Transcript
JINAD-P-MC 1 hr. 38 sec. Transcript

Chemistry, Manufacturing and Controls 2

Template Recording Duration Transcripts
VMF-A-OT (Type II) 41 min. 17 sec. Transcript
VMF-A-OT (Type V) 42 min. 33 sec. Transcript
Post Approval Submissions (supplements, MCSR) 54 min 18 sec. Transcript

Target Animal Review Divisions 1

Template Recording Duration Transcripts
INAD-A-OT 8 min. 36 sec. Transcript
INAD-Es 4 min. 59 sec. Transcript
INAD-O-OT 14 min. 15 sec. Transcript
ADAA Combination Submissions 28 min. 5 sec. Transcript
NADA-A-OT Free Choice Feeds 18 min. 26 sec. Transcript

Target Animal Review Divisions 2

Template Recording Duration Transcripts
INAD-Ms 14 min. 34 sec. Transcript
NADA-A-OT 22 min. 41 sec. Transcript
Meeting Requests 46 min. 47 sec. Transcript

Environmental/Target Animal Review Divisions 3

Template Recording Duration Transcripts
INAD-X-CE 15 min. 52 sec. Transcript
INAD-P-NV 34 min. 53 sec. Transcript
INAD-P-EF 41 min. 49 sec. Transcript

Generic Review Division

Template Recording Duration Transcripts
JINAD-A-OT 18 min. Transcript
JINAD-Z-OM 19 min. Transcript
ANADA-A-OT Admin 19 min. Transcript
ANADA-A-OT Traditional 33 min. Transcript

Webinar 3: Follow-up Question and Answer Session

Need Help?

Email us at cvmesubmitter@fda.hhs.gov

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