FDA’s Benefit-Risk Framework Should Be Used Earlier In Development, Firms Say
Executive Summary
Early discussions based on the framework could engender more efficient drug reviews and aid industry in decisions on clinical programs, BIO and PhRMA note in comments to the agency.
You may also be interested in...
“Complete Response” Letters Might Include Benefit-Risk Framework Discussion
FDA official says idea could be helpful; meanwhile, sponsors and others remain concerned about the framework’s undefined decision-making methods.
FDA’s Structured Benefit-Risk Assessment Framework To Come Online In FY 2014
Drug reviews will include a benefit-risk summary assessment that states the rationale for regulatory action on a drug or biologic application and explains how differences of opinion among reviewers were resolved.
REMS Assessments Could Measure Behavior, Not Just Knowledge, Industry Tells FDA
Lilly suggests a hierarchy of metrics at an agency workshop: At the lower end, surveys could elicit respondents’ knowledge about a drug’s risk, but also seek information about their behavior and the impact of the REMS on access to the medication; for riskier drugs, secondary data could be utilized to assess behavior; for the riskiest drugs, the effect of behavior on outcomes could be assessed.