FDA Guidance: Challenges and Opportunities #podcast #FDA #precisionmedicine

The full article for this interview is available on Oncology Data Advisor.

The FDA’s latest draft guidance on accelerated approvals and confirmatory trials introduces stricter requirements to ensure that early response rates translate into real patient benefits. In this discussion, Dr. Harpreet Singh, Chief Medical Officer at Precision for Medicine and former FDA Division Director of Oncology, explores the implications for oncology drug development, including key regulatory changes, challenges for biotech companies, and strategies to navigate the evolving landscape.

Learn how these changes aim to prevent delays in confirmatory trials, reduce “dangling approvals,” and improve the safety and efficacy of novel therapies. Dr. Singh provides expert insights on optimizing early-phase trials, securing regulatory alignment, and balancing accelerated and traditional approval pathways in oncology drug development.

#FDAApproval #OncologyDrugs #AcceleratedApproval #ClinicalTrials #CancerResearch #DrugDevelopment #RegulatoryAffairs #Biotech #PrecisionMedicine #PharmaNews

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