Description
The following is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research. For ease of reference, the numbers assigned to the questions are consecutive throughout this section. These questions and answers are organized as follows.
Scope & Applicability
Product Classes
3Includes radioactive biological products labeled with a radionuclide; Compounds with radionuclides used in research studies.; Drugs labeled with a radionuclide used in research.; Drugs labeled with radionuclides used in human research.; subject of the guidance and dose limits; Drugs used in basic science research under 21 CFR 361.1.; Subject of the RDRC review and checklist
IVDs requiring UDI on labels
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Stakeholders
3Person who may give consent on behalf of a participant
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Governs top dose in clinical studies
Identified Hazards
Hazards
1Must be disclosed and certified against by expert panel members.
Related CFR Sections (6)
- 21CFR361.1§ 361.1 Radioactive drugs for certain research uses.
(a) Radioactive drugs (as defined in § 310.3(n) of this chapter ) are generally recognized as safe and effective when administered, under the conditions set forth in paragraph (b) of this section, to human research subjects during the course of a research project intended to obtain basic informationRead full regulation →
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order: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 →
- 21CFR56.107§ 56.107 IRB membership.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members,Read full regulation →
- 21CFR56.106§ 56.106 Registration.
(a) Who must register? Each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the act and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits forRead full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-06-18
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
See Also (8)
- Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry (Status: Final)
- Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry (Status: Final)
- Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBs (Status: Final)
- Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (Status: Final)
- PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (Status: Final)
- Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (Status: Final)
- PET Drug Products - Current Good Manufacturing Practice (CGMP) (Status: Final)
- Exploratory IND Studies: Guidance for Industry, Investigators, and Reviewers (Status: Final)