FDA Combo Approvals Could Follow Drug-Eluting Stent Template
Executive Summary
FDA should use its approval of drug-eluting stents as the template for combination product approvals, attendees recommended at FDA's drug delivery workshop July 8 in Bethesda, Md
You may also be interested in...
FDA Drug Delivery Systems Workshop Slated For July 8
FDA is soliciting feedback on regulatory challenges posed by novel drug and biologics delivery systems, and steps the agency can take to ease the regulatory pathway
J&J Cypher Stent Approval Includes Rapamune Label Change Monitoring
Post-marketing commitments for Johnson & Johnson/ Cordis' Cypher sirolimus-eluting stent include close monitoring of labeling changes for Wyeth's sirolimus product Rapamune
FDA Combo Product Letters Tackle Postmarketing Issues; Guidance Planned
FDA's Office of Combination Products plans to issue guidance on postmarketing requirements included in "request for designation" letters