FDA Seeks Dedicated Meta-Analysis Team As Part Of PDUFA V User Fee Funding
Executive Summary
FDA wants to create a meta-analysis team to conduct its own studies with funding from the next round of application user fees.
You may also be interested in...
PDUFA V Agreement Set In Four Areas, But Broad FDA/Industry Talks Continue
FDA and industry have reached agreement on four issues in the Prescription Drug User Fee Act reauthorization, including adjustments to risk-benefit policy and creation of a meta-analysis team.
PDUFA V Agreement Set In Four Areas, But Broad FDA/Industry Talks Continue
FDA and industry have reached agreement on four issues in the Prescription Drug User Fee Act reauthorization, including adjustments to risk-benefit policy and creation of a meta-analysis team.
Avandia Shows FDA Discomfort With Meta-Analyses, Observational Studies In Decision-Making
The strong, continued resistance by FDA Center for Drug Evaluation and Research officials to rely on meta-analyses and observational studies as the basis for removing Avandia from the market suggests it will take time for the agency to become comfortable using the active surveillance system envisioned under the Sentinel Initiative in regulatory decision-making.