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Drug Administration will be providing a public analysis of industry “diversity plans” submitted in response to a 2022 draft guidance on promoting enrollment from traditionally under-represented populations as it prepares to implement a statutory codification of the policy later this year.
Diversity Plans For US FDA: Oncology Experience Will Inform New Policies
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.
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Agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
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The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
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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.
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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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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.