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

Combo Products Would Usually Require Payment Of Only One User Fee, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Draft guidance on user fees states that the amount paid would be equivalent to one PDUFA fee when FDA requires two applications for an “innovative combination product.” FDA is developing guidance on when single or multiple applications should be submitted.

You may also be interested in...



Separate Marketing Applications Will Be Assessed Their Own User Fees – FDA

Agency guidance discusses when to submit a separate application as opposed to a supplement. The Medicare Rx law may require a separate application to be submitted if there is a change to the reference listed drug, the guidance states.

Separate Marketing Applications Will Be Assessed Their Own User Fees – FDA

Agency guidance discusses when to submit a separate application as opposed to a supplement. The Medicare Rx law may require a separate application to be submitted if there is a change to the reference listed drug, the guidance states.

Industry Seeks Clarification On Applicability Of Regs For Combo Products

Comments on FDA's combination products draft guidance ask for clarification of the regulatory requirements when the separate components are produced as a single entity or co-packaged. FDA views the dual applicability as manageable since there is "considerable overlap" between pharmaceutical cGMPs and device quality system regs.

Topics

UsernamePublicRestriction

Register

OM017175

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