COMBO DRUG/DEVICE PRODUCT SPONSORS BEING SURVEYED BY FDA
Executive Summary
COMBO DRUG/DEVICE PRODUCT SPONSORS BEING SURVEYED BY FDA in an effort to evaluate the effectiveness of the agency's combination product program, Ombudsman and Chief Mediator Amanda Pedersen told a Food & Drug Law Institute conference in Washington, D.C. June 16. The agency is surveying all manufacturers that have submitted requests that FDA determine the center with primary review responsibility for a combination product (also known as requests for designation).