Changes in FDA Guidances
The new Administration has taken a strong stance against DEI. The Administration’s philosophical position has had an effect on FDA, at least in terms of the guidances that are publicly available and potentially regarding the programs, and the way FDA reviews medical products.
Of course, medical products are used on a diverse population — most medical devices are not sex or race specific. So it follows that those products should be tested to ensure safety and efficacy on those populations. Guidances to provide advice to industry about efforts to do so are being removed from FDA.gov.
I am attempting to track these changes
This will be an evolving page
Searching for guidance with the word “women” yields zero results (1/24)
Searching for guidance with the word “race” yields zero results (1/24)
Oncology Center of Excellence Equity page is dark: https://www.fda.gov/about-fda/oncology-center-excellence/oce-equity-program (1/24)
Diversity Action Plan page is no longer up (2/3)
is no longer accessible but the page is up: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies and the information is still available at Regulations.gov (1/24).
RFK Jr told Sen Lujan, during his confirmation hearing, that he would commit to reinstating and finalizing the guidance (1/29)
CDRH Health of Women page is dark: https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-health-women-program (1/24)
I have a copy here.
The FDA birth control page is still up: https://www.fda.gov/consumers/womens-health-topics/birth-control (1/24)
FDA OWH page is still up: https://www.fda.gov/about-fda/office-commissioner/office-womens-health (1/24)
Study of Sex and Gender Differences guidance is no longer up (2/3)
The 2014 guidance on Evaluation of Sex-Specific Data in Medical Device Clinical Studies is still up: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-sex-specific-data-medical-device-clinical-studies-guidance-industry-and-food-and-drug (1/24)
The updated version of that guidance is no longer available on FDA.gov but can still be found in the Federal Register: https://www.federalregister.gov/documents/2025/01/07/2024-31526/evaluation-of-sex-specific-and-gender-specific-data-in-medical-device-clinical-studies-draft (1/24)
Unrelated to DEI, FDA is delaying the effective date of of the final rule, “Nonprescription Drug Product With an Additional Condition for Nonprescription Use” from January 27 to March 21, 2025
Not guidance related but:
FDA cancelled its 1/30 meeting on Real World Evidence
FDA pulled out of its numerous speaking slots at an ASCGT workshop on gene therapy
FDA’s 2/5 meeting on ERLA opioids has been postponed (per Sue Sutter @ PinkSheet)
FDA’s 2/24 AdComm on a Novartis rare disease drug was postponed (per Sue Sutter @ PinkSheet). It appears that the comment period still closes 2/21.
RAPS has a good overview the changes