Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Generic Drug Fees Could Be Based On Product Complexity

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA seeks comments at Sept. 17 public hearing on issues surrounding development of an ANDA user fee program, including whether applications for more complex products should carry a higher fee and whether fees should be used to support postmarketing safety oversight.

You may also be interested in...



Generic User Fee Negotiations: Should Different Kinds Of ANDAs Pay More?

The generic industry largely rejects one of the theoretical structures floated by FDA for an ANDA user fee program: paying more for reviews of complex drugs. But the concept does have support from many consumer advocates and at least one member of the Generic Pharmaceutical Association's board of directors, suggesting that the approach might continue to guide regulatory thinking even if it is not part of the final deal between industry and the agency.

Generic User Fee Negotiations: Should Different Kinds Of ANDAs Pay More?

The generic industry largely rejects one of the theoretical structures floated by FDA for an ANDA user fee program: paying more for reviews of complex drugs. But the concept does have support from many consumer advocates and at least one member of the Generic Pharmaceutical Association's board of directors, suggesting that the approach might continue to guide regulatory thinking even if it is not part of the final deal between industry and the agency.

ANDA User Fee Negotiations: A Big-Firm Coalition Tackles The Big Backlog

FDA has long negotiated its brand user fee program with two distinct but closely aligned industry groups: the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization. Now the agency will be using those same discussion techniques as it develops the generic drug user fee program.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS071138

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