Update

ACT-AD Submits Comments to FDA on the Agency’s Draft Prescription Drug User Fee Act V Benefit-Risk Plan

ACT-AD submitted comments to the U.S. Food and Drug Administration on the Agency’s Draft Prescription Drug User Fee Act V Benefit-Risk Plan. The comments recognize the FDA for pursuing their planned patient-focused drug development activities despite having user fees to support these activities sequestered under the Budget Control Act of 2011. The comments also suggest that FDA’s final plan should include details on how early in the drug development and review processes patient views will now be included in conversations between the FDA’s product review divisions and a drug/product sponsors, the amount of information the Agency intends to solicit from patients, and the mechanisms it plans to use to garner patient and caregiver input.
View Comments

Categories:
Uncategorized