Submitting Debarment Certification Statements

Description

Section 306(k) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 335a(k)), as amended by the Generic Drug Enforcement Act of 1992 (GDEA), requires that drug product applicants certify that they did not and will not use in any capacity the services of any debarred persons in connection with a drug product application. If the application is an abbreviated new drug application (ANDA), it must also include a list of all convictions described under section 306(a) and (b) of the Act (21 U.S.C. 335a(a) and (b)) that occurred within the previous 5 years and were committed by the applicant or affiliated persons responsible for the development or submission of the ANDA.

Scope & Applicability

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

• 21CFR312.40§ 312.40 General requirements for use of an investigational new drug in a clinical investigation.

  (a) An investigational new drug may be used in a clinical investigation if the following conditions are met:Read full regulation →

• 21CFR511.1§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.

  (a) New animal drugs for tests in vitro and in laboratory research animals.Read full regulation →

• 21CFR314.60§ 314.60 Amendments to an unapproved NDA, supplement, or resubmission.

  (a) Submission of NDA. FDA generally assumes that when an original NDA, supplement to an approved NDA, or resubmission of an NDA or supplement is submitted to the Agency for review, the applicant believes that the Agency can approve the NDA, supplement, or resubmission as submitted. However, the appRead full regulation →

• Clinical Investigator (Sponsor)

  Pamela K. Den Besten, DDS, MS

  2025-09-30

• Clinical Investigator (Sponsor)

  American Behavioral Research Institute, LLC

  2025-06-10

• Clinical Investigator

  ISOThrive, Inc.

  2025-02-11

• Clinical Investigator (Sponsor)

  "David M. Lubeck, M.D./Arbor Centers for EyeCare

  2022-11-29

• Bioresearch Monitoring Program/IRB

  RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.

  2021-10-12

• Bioresearch Monitoring Program

  Kaleido Biosciences, Inc.

  2021-09-07

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