Submit Feedback by 09/26/2024
Though you possibly can touch upon any steerage at any time (see 21 CFR 10.115(g)(5)), to make sure that the FDA considers your touch upon a draft steerage earlier than it begins work on the ultimate model of the steerage, submit both on-line or written feedback on the draft steerage earlier than the shut date.
If unable to submit feedback on-line, please mail written feedback to:
Dockets ManagementFood and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852
All written feedback needs to be recognized with this doc’s docket quantity:
Issued by:
Steering Issuing Workplace
Oncology Heart of Excellence
Heart for Biologics Analysis and Analysis
Heart for Drug Analysis and Analysis
Heart for Units and Radiological Well being
Workplace of the Commissioner, Workplace of Minority Well being and Well being Fairness
Workplace of the Commissioner, Workplace of Girls’s Well being
This draft steerage describes the shape, content material, and method of range motion plans, the relevant medical merchandise, and scientific research for which a range motion plan is required, the timing and course of for submitting range motion plans, and the standards and course of by which FDA will consider sponsors’ requests for waivers from the requirement to submit a Range Motion Plan. It replaces the draft steerage for business entitled “Range Plans to Enhance Enrollment of Individuals From Underrepresented Racial and Ethnic Populations in Medical Trials,” revealed April 14, 2022
FDA is issuing this steerage as mandated underneath part 3602 of FDORA, which requires that FDA replace or challenge steerage regarding the format and content material of range motion plans required by sections 505(z) and 520(g) of the FD&C Act (21 U.S.C. 355(z) and 360j(g) as amended by part 3601 of FDORA.
Content material present as of:
06/26/2024