Comment from Mitchell Berger
AnonymousSupportIndividual
Summary: Mitchell Berger, commenting in a personal capacity, supports the FDA's efforts to accelerate early-stage clinical development through the proposed pilot program. He advocates for prioritizing drug repurposing, ensuring clear ethical safeguards and data ownership rules, and securing adequate FDA staffing and resources.
Dear Mr. Cook: In reviewing the above RFI, I support FDA’s efforts to accelerate early stage clinical development and encourage the agency to ensure that the pilot meaningfully supports drug and biologic repurposing, maintains strong ethical safeguards, and provides adequate resources for FDA staff. Please note that these comments reflect solely my personal views and not those of an agency, organization, or other individual(s). Comment attached below.Sincerely, Mitchell Berger