Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Combo Product Letters Tackle Postmarketing Issues; Guidance Planned

Executive Summary

FDA's Office of Combination Products plans to issue guidance on postmarketing requirements included in "request for designation" letters

You may also be interested in...



FDA Combo Approvals Could Follow Drug-Eluting Stent Template

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

FDA Combo Approvals Could Follow Drug-Eluting Stent Template

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

FDA Combination Product Review Policy Update Includes Tracking System

FDA drug and biologic reviewers should track consultative or collaborative reviews on combination products through each center's tracking system, a Feb. 14 update to the agency's policies and procedures states

UsernamePublicRestriction

Register

PS041562

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel