US FDA Expanded Access Pilot Launching Soon With Staffing Questions Unanswered
New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.
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Analysis presented at ASCO concludes that pilot program helped physicians request access to investigational drugs for individual patients. Now agency officials are suggesting an expansion of the project.
Many stakeholders interviewed by the GAO find the US FDA's updated guidance on treatment of adverse event data gathered under expanded access to be helpful, but some continue to be concerned that the data will be used to negatively impact development programs.
Patient advocates asked what they could do after US FDA’s complete response letter for the proposed Duchenne drug, but Sarepta's CEO said the company would get the product back on track to approval itself, a marked contrast to engaged role the community played the last time the firm ran into a roadblock at the agency.