CHAPTER 48 - 7348.809 Bioresearch Monitoring

Scope & Applicability

Regulatory Context

• 21CFR50.54§ 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

  If an IRB does not believe that a clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter and involving children as subjects meets the requirements of § 50.51 , § 50.52 , or § 50.53 , the clinical investigation may proceed only if:Read full regulation →

• 21CFR56.121§ 56.121 Disqualification of an IRB or an institution.

  (a) Whenever the IRB or the institution has failed to take adequate steps to correct the noncompliance stated in the letter sent by the agency under § 56.120(a) , and the Commissioner of Food and Drugs determines that this noncompliance may justify the disqualification of the IRB or of the parent inRead full regulation →

• 21CFR56.120§ 56.120 Lesser administrative actions.

  (a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA investigator during an inspection, the inspector will present an oral or written summary of observations to an appropriate representative of the IRB. The Food and Drug Administration may subsequentlRead full regulation →

• 21CFR56.114§ 56.114 Cooperative research.

  In complying with these regulations, institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.Read full regulation →

• 21CFR56.102§ 56.102 Definitions.

  As used in this part:Read full regulation →

• 21CFR50.24§ 50.24 Exception from informed consent requirements for emergency research.

  (a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is Read full regulation →

• 21CFR50.23§ 50.23 Exception from general requirements.

  (a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:Read full regulation →

• 21CFR50.22§ 50.22 Exception from informed consent requirements for minimal risk clinical investigations.

  The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b) , or may waive thRead full regulation →

• 21CFR50.25§ 50.25 Elements of informed consent.

  (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →

• 21CFR812.150§ 812.150 Reports.

  (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:Read full regulation →

• 21CFR312.66§ 312.66 Assurance of IRB review.

  An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in thRead full regulation →

• 21CFR56.108§ 56.108 IRB functions and operations.

  In order to fulfill the requirements of these regulations, each IRB shall:Read full regulation →

• 21CFR56.115§ 56.115 IRB records.

  (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:Read full regulation →

• 21CFR56.111§ 56.111 Criteria for IRB approval of research.

  (a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →

• 21CFR56.109§ 56.109 IRB review of research.

  (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.Read full regulation →

• 21CFR56.113§ 56.113 Suspension or termination of IRB approval of research.

  An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for Read full regulation →

• 21CFR814.3§ 814.3 Definitions.

  For the purposes of this part:Read full regulation →

• 21CFR56.110§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

  (a) The Food and Drug Administration has established, and published in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, through periodic republication in the Federal Register.Read full regulation →

• 21CFR812.66§ 812.66 Significant risk device determinations.

  If an IRB determines that an investigation, presented for approval under § 812.2(b)(1)(ii) , involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in § 812.30(a) .Read full regulation →

• 21CFR812.20§ 812.20 Application.

  (a) Submission.Read full regulation →

• In Vivo Bioavailability-Bioequivalence Studies – Clinical

  Maria A. Carballosa, M.D.

  2025-12-23

• Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

  Celularity, Inc

  2025-12-09

• Sponsor/Investigator

  Verdure Sciences, Inc.

  2025-11-18

• Clinical Investigator (Sponsor)

  Pamela K. Den Besten, DDS, MS

  2025-09-30

• Clinical Investigator/Sponsor

  Ralph A. DeFronzo, M.D.

  2025-09-23

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Clinical Investigator

  Peter Michael, M.D.

  2025-07-01

• Clinical Investigator (Sponsor)

  American Behavioral Research Institute, LLC

  2025-06-10

• Bioresearch Monitoring Program

  Amy Lightner, MD

  2025-06-03

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