Scrip 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


U.S. Generic User Fees Might Combine Inspection Visits, Boost Foreign Cooperation

This article was originally published in PharmAsia News

Executive Summary

U.S. FDA and the generic industry are considering ideas for combining inspections to reduce the number of visits from regulators as part of user fee discussions, while industry is concerned changes could affect cooperation with foreign entities

You may also be interested in...

Generic User Fee Negotiators Struggling To Meet June Deadline

FDA does not want to rush, but may consider splitting negotiators into small groups to deal with specific issues.

Generic User Fees Would Create 10-Month ANDA Review Time

Annual revenue of $250 million to $300 million in generic drug user fees is discussed as FDA unveils its "four walls and a roof" guiding principles.

FDA-EMA-TGA Joint Inspection Program To Be Permanent; Other Collaborations Expand

FDA, the European Medicines Agency and Australian Therapeutic Goods Administration intend to make permanent a pilot program allowing for joint facility inspections in what would be another step toward more U.S. reliance on foreign regulator and third-party data and a reduction in inspection burden.

Related Content




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