Harpreet Singh, MD

FDA's new guidance clarifies overall survival data collection in clinical trials, emphasizing long-term follow-up, subgroup analysis, and trial design considerations.

Dr Harpreet Singh explores the FDA's new guidance on overall survival as a clinical trial endpoint, addressing its implications and challenges in oncology.

Experts emphasize the need for regulatory alignment between the FDA and EMA to streamline radiopharmaceutical development and enhance patient access.

Dr Harpreet Singh discusses the FDA's new guidance on radiopharmaceutical dosing, emphasizing dose justification and data integration for patient safety.

Dr Harpreet Singh discusses the FDA's draft guidance on radiopharmaceutical dosing, highlighting significant shifts in dose limits and safety monitoring for clinical trials.

Harpreet Singh, MD, former FDA director, discusses the FDA's new draft guidance on radiopharmaceutical dosing and its relation to Project Optimus.