PhRMA Asks FDA To Clarify Continuous Marketing Pilot Program Expectations
Executive Summary
FDA should prospectively define performance baselines for its continuous marketing application pilot programs, the Pharmaceutical Research & Manufacturers of America said
You may also be interested in...
FDA Review Divisions Get More Discretion In Continuous Application Pilots
FDA review divisions can negotiate with sponsors to allow submission of more than one "reviewable unit" under the agency's final guidance on the "continuous marketing applications" Pilot 1 program
FDA Review Divisions Get More Discretion In Continuous Application Pilots
FDA review divisions can negotiate with sponsors to allow submission of more than one "reviewable unit" under the agency's final guidance on the "continuous marketing applications" Pilot 1 program
FDA Biotech Consultants Should Be Vetted By Companies, BIO Says
The Biotechnology Industry Organization is asking FDA to allow sponsors to review the agency's choice of outside consultants as part of its clinical protocol evaluation program