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Diversity Plans For US FDA: Oncology Experience Will Inform New Policies

 
• By Laura Helbling

US FDA will be transitioning from the ‘diversity plans’ outlined in recent guidance to the new, legislatively directed ‘diversity action plans’ by the end of 2023. The oncology group is leading the way in gathering early perspectives on industry approaches.

diversity plans
• Source: Shutterstock

The US Food and Drug Administration will be providing a public analysis of industry “diversity plans” submitted in response to a 2022 draft guidance on promoting enrollment from traditionally under-represented populations as it prepares to implement a statutory codification of the policy later this year.

Oncology Center of Excellence Associate Director, Science & Policy Program to Address Disparities Lola Fashoyin-Aje described FDA’s experience thus far with diversity plans at a July meeting on “Advancing...

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More from Duke-Margolis Center for Health Policy

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

Agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches

 
• By Sue Sutter

The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.

Preterm Birth Prevention Studies Need To Look Beyond Makena Endpoints, Experts Say

 
• By Sue Sutter

Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’

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ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.