FDA Expedited Pathways Guidance Expands Range Of Eligible Products
Drugs intended to prevent a serious condition or reduce likelihood of disease progression may qualify, as may products intended to diminish serious adverse events associated with current treatment.
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Law defines QIDP as antibacterials and antifungals intended to 'treat' serious infections, but FDA now interprets provision more broadly to include preventive and diagnostic products, agency says in a new draft guidance clarifying program's requirements and benefits for sponsors
Letter being circulated by Rep. Bilirakis states the agency’s draft expedited approval guidance does not provide clarity for rare disease sponsors to use accelerated approval.
FDA Cancer Center’s New ‘Projects’ Focus On Early Endpoints; Asian American, Native Hawaiian Populations
Launched in 2023, Project Endpoint focuses on advancing understanding of early, novel endpoints, while Project ASIATICA aims to bring greater awareness of challenges and health disparities faced by Asian American, Native Hawaiian, and Other Pacific Islander patients with cancer.