Matthew Teltser: Final Debarment Order
Published Date: 2/6/2026
Notice
Summary
Matthew Teltser is permanently banned from working with any company that has drug products approved or waiting for approval because he was convicted of a serious crime related to drug development. He didn’t respond to the FDA’s notice, so the ban started on February 6, 2026. He can apply to end this ban anytime, but it won’t be easy or quick.
Analyzed Economic Effects
5 provisions identified: 1 benefits, 3 costs, 1 mixed.
Civil Penalties for Employers Who Hire Debarred Person
Any person with an approved or pending drug product application who knowingly employs, retains as a consultant or contractor, or otherwise uses the services of Matthew Teltser during his period of debarment will be subject to civil money penalties under section 307(a)(6) of the FD&C Act. The debarment period began February 6, 2026.
Individual Penalties for Providing Services During Debarment
If Matthew Teltser provides services in any capacity to a person with an approved or pending drug product application during his debarment, he will be subject to civil money penalties under section 307(a)(7) of the FD&C Act. The debarment is effective February 6, 2026.
FDA Will Not Accept ANDAs From Debarred Individual
During his period of debarment, FDA will not accept or review any abbreviated new drug application (ANDA) from Matthew Teltser, except in connection with an audit under section 306 of the FD&C Act. This restriction began on February 6, 2026.
Permanent FDA Debarment Effective Feb 6, 2026
The FDA permanently debarred Matthew Teltser from providing services in any capacity to a person that has an approved or pending drug product application, effective February 6, 2026. The debarment follows his June 10, 2025 federal conviction for making a false statement and his failure to request a hearing after receiving FDA's notice on September 8, 2025.
Right to Apply for Special Termination; Public Filing Rules
Dr. Teltser may apply at any time for special termination of debarment under section 306(d)(4) of the FD&C Act. Applications submitted electronically to https://www.regulations.gov will be posted publicly unless submitted as a written/paper confidential submission following FDA's instructions.
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