- FDA Issues Overdue Guidance on Diversity Action Plans in Drug ...🔍
- FDA Issues Overdue Draft Guidance on Clinical Trial Diversity ...🔍
- FDA Issues Long|Awaited Diversity Action Plan Guidance🔍
- Better Late Than Never – Unpacking FDA's Highly Anticipated 🔍
- FDA Guidance Provides New Details on Diversity Action Plans ...🔍
- NHC Comments on Landmark FDA Guidance for Diversity in Clinical ...🔍
- Clinical Trial Diversity Action Plan Waivers Will Be 'Very Rare🔍
- FDA Takes Next Step in Advancing Diversity in Clinical Studies🔍
FDA Issues Overdue Guidance on Diversity Action Plans in Drug ...
FDA Issues Overdue Guidance on Diversity Action Plans in Drug ...
On June 26, 2024, FDA released its long-awaited draft guidance on Diversity Action Plans to increase enrollment of underrepresented populations in clinical ...
FDA Issues Overdue Draft Guidance on Clinical Trial Diversity ...
Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve ...
FDA Issues Long-Awaited Diversity Action Plan Guidance
Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, ...
Better Late Than Never – Unpacking FDA's Highly Anticipated (and ...
The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs ...
FDA Guidance Provides New Details on Diversity Action Plans ...
Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from ...
NHC Comments on Landmark FDA Guidance for Diversity in Clinical ...
The National Health Council (NHC) appreciates the opportunity to comment on the Food and Drug Administration's (FDA) draft guidance for industry ...
Clinical Trial Diversity Action Plan Waivers Will Be 'Very Rare,' US ...
FDA was supposed to issue a guidance on the “format and content” of the plans within one year after the law was signed (29 December 2022) so ...
FDA Takes Next Step in Advancing Diversity in Clinical Studies
While the Draft Guidance officially replaces FDA's April 2022 draft guidance entitled “Diversity Plans to Improve Enrollment of Participants ...
Summing Up The FDA's Long-Anticipated Draft Guidance On ...
29, 2022, required, in part, that drug and device manufacturers submit Diversity Action Plans (DAPs) to the FDA for certain clinical studies ...
FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans
A Diversity Action Plan is required for a clinical investigation of a new drug that is a phase 3 study or, as appropriate, another pivotal ...
AgencyIQ — FDA just published its Diversity Action Plan guidance ...
Per that statutory requirement, “a Diversity Action Plan is required for a clinical investigation of a new drug that is a phase 3 study (as ...
FDA's Diversity Action Plans for Clinical Trials: Key Deadlines and ...
FDORA required FDA to issue the Draft Guidance by the end of December 2023 – better late than never! – and FDA must finalize the Draft Guidance ...
Comment Request; Diversity Action Plans for Clinical Studies
To comply with this requirement, FDA is publishing this notice of the proposed collections of information as set forth in the draft guidance for ...
FDA publishes updated draft guidance on clinical trial diversity
Diversity action plans are required for phase 3 trials or other pivotal clinical drug studies and investigational device exemption (IDE) ...
'Do It Or We're Not Going To Approve Your Drug:' Industry Reps Ask ...
The FDA's diversity action plan guidance is more than five months delayed. Co-writing protocols with patients and investigators serving diverse ...
Finally! FDA Issues Updated Draft Guidance on Diversity Action ...
On June 28, 2024,1FDA, Notice of availability, Diversity Action Plans To Improve Enrollment of Participants From Underrepresented ...
Gibson Dunn on X: "The U.S. Food and Drug Administration (FDA ...
... guidance on Diversity Action Plans in clinical trials of drugs and devices ... FDA Issues Overdue Guidance on Diversity Action Plans in ...
An Overview of FDA Diversity-Related Documents for Clinical Trials
Pursuant to FDORA, the FDA must issue updated draft guidance on Diversity Action Plans. Recent FDA Guidance and Action – January 2024 ...
FDA's Path Toward Diversity in Clinical Trials: The DEPICT Act and ...
The DEPICT Act requires the FDA to require clinical trial sponsors to submit Diversity Action Plans with their protocols for Phase III or other pivotal trials.
FDA Issues Overdue Draft Guidance on Clinical Trial Diversity ...
Under FDORA, Diversity Action Plans will be required for Phase 3 or other pivotal trials for drugs and for most device clinical trials, although ...