Scrip 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

Dingell bill seeks US generic user fees for pre-approval inspections

This article was originally published in Scrip

Executive Summary

Three US Democratic lawmakers on the House energy and commerce committee, including Representative John Dingell, have introduced a revised version of a 2008 draft food and safety bill that aims to strengthen theFDA's regulatory powers and shore up its overseas inspections through new industry user fees. The bill follows the same broad scope as outlined last year, but in a first, the bill would require user fees from generics firms for pre-approval inspections for generic drugs.

Latest Headlines
See All
UsernamePublicRestriction

Register

SC031523

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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