FDA Stays In Hot Seat On Capitol Hill; PDUFA No Longer Drives Legislation
Executive Summary
FDA operational problems will continue to be a prime target for congressional oversight, a House Republican staffer advised the Food and Drug Law Institute annual meeting April 23
You may also be interested in...
FDA Oversight Of Clinical Trials Could Be Strengthened After Avandia Report
FDA's oversight of clinical trials didn't reach the headlines during coverage of the Senate Finance Committee's report on Avandia safety, but pressure on the agency from Sens. Max Baucus, D-Mont., and Chuck Grassley, R-Iowa, could have far-reaching consequences for how industry conducts research for products in the future
FDA Oversight Of Clinical Trials Could Be Strengthened After Avandia Report
FDA's oversight of clinical trials didn't reach the headlines during coverage of the Senate Finance Committee's report on Avandia safety, but pressure on the agency from Sens. Max Baucus, D-Mont., and Chuck Grassley, R-Iowa, could have far-reaching consequences for how industry conducts research for products in the future
IRB Quality Concerns Take Center Stage After FDA Clamps Down On Coast
Quality has moved up in importance as a criterion for selecting an institutional review board following an April 14 FDA warning letter to Coast IRB and the company's agreement to halt enrollment in clinical studies it monitors