FDA’s Breakthrough Products: Could Patients Drive The Designations?
This article was originally published in The Pink Sheet Daily
Sen. Bennet is receiving letters from patients asking to talk with FDA about products they think could be a breakthrough.
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Success of enhanced communications in particular made one stakeholder wonder whether FDA could use it with non-breakthrough applications.
Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.
FDA report on CFS/myalgic encephalomyelitis is first of its kind from the patient-focused drug development initiative under PDUFA V. Incorporating comments from hundreds of patients and caregivers into a structured framework shows how the input may support a benefit/risk assessment for new products.