Description
Q2: Do you have to live or intend to live in a state in which same-sex marriage is legal for FDA’s regulations using the terms "spouse" or "family" to apply to you?
Scope & Applicability
Product Classes
1Products subject to clinical investigation guidance.
Stakeholders
8members of the NMQAAC
indexing new animal drugs
subject to financial disclosure requirements
Governs top dose in clinical studies
Person authorized to provide consent on behalf of the patient if needed.
requiring clinical investigators to disclose the financial interests and arrangements of their same-sex spouses.
FDA will interpret the terms spouse and family in its regulations to include same-sex spouses.
FDA will interpret the terms spouse and family in its regulations to include same-sex spouses.; interpreted to include same-sex spouse
Related CFR Sections (7)
- 21CFR900.2§ 900.2 Definitions.
The following definitions apply to subparts A , B , and C of this part :Read full regulation →
- 21CFR516.141§ 516.141 Qualified expert panels.
(a) Establishment of a qualified expert panel. Establishing a qualified expert panel is the first step in the process of requesting the addition of a new animal drug to the index. A qualified expert panel may not be established until FDA has determined that the new animal drug is eligible for indexiRead 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 →
- 21CFR54.2§ 54.2 Definitions.
For the purposes of 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 →
- 21CFR50.3§ 50.3 Definitions.
As used in this part:Read full regulation →
- 21CFR20.44§ 20.44 Expedited processing.
(a) The Food and Drug Administration will provide expedited processing of a request for records when the requester demonstrates a compelling need, or in other cases as determined by the agency. A compelling need exists when:Read full regulation →
See Also (8)
- Bioresearch Monitoring Technical Conformance Guide (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors (Status: Final)
- Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry (Status: Final)
- Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)