Notice2026-02349
Matthew Teltser: Final Debarment Order
Primary source
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Published
February 6, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Matthew Teltser from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Matthew Teltser was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Dr. Teltser was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. As of November 14, 2025 (more than 30 days after receipt of the notice), Dr. Teltser has not responded. Dr. Teltser's failure to respond and request a hearing constitutes a waiver of Dr. Teltser's right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 91 Issue 25 (Friday, February 6, 2026)</title>
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[Federal Register Volume 91, Number 25 (Friday, February 6, 2026)]
[Notices]
[Pages 5495-5497]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02349]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1956]
Matthew Teltser: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Matthew Teltser from providing services in
any capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Matthew Teltser was
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of any drug product. Dr. Teltser was given notice of the
proposed permanent debarment and an opportunity to request a hearing to
show why he should not be debarred within the timeframe prescribed by
regulation. As of November 14, 2025 (more than 30 days after receipt of
the notice), Dr. Teltser has not responded. Dr. Teltser's failure to
respond and request a hearing constitutes a waiver of Dr. Teltser's
right to a hearing concerning this matter.
DATES: This order is applicable February 6, 2026.
ADDRESSES: Any application by Dr. Teltser for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) may be submitted at any time as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[[Page 5496]]
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2025-N-1956. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed
except in accordance with 21 CFR 10.20 and other applicable disclosure
law. For more information about FDA's posting of comments to public
dockets, see 80 FR 56469, September 18, 2015, or access the information
at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, Food and Drug Administration, 240-402-
8743, or <a href="/cdn-cgi/l/email-protection#cda9a8afacbfa0a8a3b9be8daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="80e4e5e2e1f2ede5eef4f3c0e6e4e1aee8e8f3aee7eff6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the FD&C Act requires debarment of an
individual from providing services in any capacity to a person that has
an approved or pending drug product application if FDA finds that the
individual has been convicted of a felony under Federal law for conduct
relating to the development or approval, including the process of
development or approval, of any drug product under the FD&C Act. On
June 10, 2025, Dr. Teltser was convicted as defined in section
306(l)(1) of the FD&C Act in the U.S. District Court for the Southern
District of Florida, Fort Lauderdale Division, when the court accepted
his plea of guilty and entered judgment against him for the offense of
making a false statement in violation of 18 U.S.C. 1001(a)(2). The
underlying facts supporting the conviction are as follows:
As contained in the Information, Plea Agreement, and Factual
Proffer in support of Dr. Teltser's guilty plea, Dr. Teltser was a
licensed medical doctor who served as the clinical investigator at A&R
Research Group LLC (A&R), a medical research clinic that conducted
clinical trials on behalf of drug trial sponsors. Between at least in
or around January 2019 and continuing through at least in or around
January 2020, Dr. Teltser conducted two clinical research trials at A&R
on behalf of a drug sponsor as the clinical investigator. The two
clinical research trials concerned investigational drugs intended to
treat human subjects with moderate to severe asthma and mild to
moderate asthma (collectively, ``the asthma trials'').
As the clinical investigator, Dr. Teltser was responsible for,
among other things, personally overseeing the conduct of the studies
and study staff, performing physical examinations on study subjects,
reviewing lab results and echocardiograms, and preparing and
maintaining accurate medical records, also referred to as case
histories.
Prior to beginning the clinical trials, Dr. Teltser and A&R entered
into a Clinical Trial Agreement for each of the asthma trials with the
contract research organization which was acting on behalf of the drug
sponsor. By signing the Clinical Trial Agreements, Dr. Teltser knew he
was required, among other things, to follow the study protocol and
applicable Federal regulations. Dr. Teltser signed a Form FDA 1572,
Statement of Investigator, for at least one of the asthma trials. By
signing the Form FDA 1572, Statement of Investigator, Dr. Teltser
agreed to (1) conduct the trial according to the study protocol and in
compliance with all applicable Federal regulations; and (2) personally
conduct and supervise the trial.
Dr. Teltser's responsibilities included monitoring the safety and
well-being of subjects in the clinical trials, performing physical
examinations on subjects, and reviewing and maintaining the case
histories. The study protocols for the asthma trials required subjects
to meet certain eligibility criteria to qualify for and be enrolled in
the trials. Once enrolled in the asthma trials, the study protocols
required the subjects to submit to routine clinical procedures and
safety measurements, such as physical examinations and check of vital
signs, as well as study specific assessments, such as electrocardiogram
readings, pulmonary functions tests, and the drawing of blood samples
for hematology and clinical chemistry.
Between approximately January 23, 2020, and January 31, 2020, FDA
conducted a for-cause inspection at A&R. As part of the inspection, Dr.
Teltser was required to make records related to the asthma trials
available to the FDA investigator. The FDA investigator interviewed Dr.
Teltser as part of the inspection on or about January 31, 2020. During
the interview, Dr. Teltser knowingly and falsely stated to the FDA
investigator that he had been present at every subject visit during the
asthma trials. In fact, Dr. Teltser had not been present at every
subject visit in the asthma trials.
As a result of this conviction, FDA sent Dr. Teltser, by certified
mail, on September 2, 2025, a notice proposing to permanently debar him
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(a)(2)(A) of the FD&C Act, that Dr. Teltser
was convicted of a felony under Federal law for conduct relating to the
development or approval, including the process of development or
approval, of any drug product. The proposal informed Dr. Teltser of the
proposed debarment and offered him an opportunity to request a hearing,
providing him 30 days from the date of
[[Page 5497]]
receipt of the letter in which to file the request, and advised him
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and a waiver of any contentions concerning
this action. Dr. Teltser received the proposal and notice of
opportunity for a hearing on September 8, 2025. Dr. Teltser failed to
request a hearing within the timeframe prescribed by regulation and
has, therefore, waived his opportunity for a hearing and any
contentions concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Division of Field Enforcement Director, Office of
Inspections and Investigations, under section 306(a)(2)(A) of the FD&C
Act, under authority delegated to the Director, Division of
Enforcement, finds that Dr. Matthew Teltser has been convicted of a
felony under Federal law for conduct relating to the development or
approval, including the process of development or approval, of any drug
product under the FD&C Act.
As a result of the foregoing finding, Dr. Teltser is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(A) and 306(c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Dr. Teltser during his
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Teltser provides
services in any capacity to a person with an approved or pending drug
product application during his period of debarment he will be subject
to civil money penalties (section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review any abbreviated new drug
application from Dr. Teltser during his period of debarment, other than
in connection with an audit under section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that, for purposes of sections 306
and 307 of the FD&C Act, a ``drug product'' is defined as a ``drug
subject to regulation under section 505, 512, or 802 of the FD&C Act
[(21 U.S.C. 355, 360b, 382)] or under section 351 of the Public Health
Service Act [(42 U.S.C. 262)]'' (section 201(dd) of the FD&C Act (21
U.S.C. 321(dd))).
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-02349 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 6, 2026.
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