Pink Sheet is part of the Business Intelligence Division 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

In Brief: FDA user fee cover sheet

This article was originally published in The Tan Sheet

Executive Summary

FDA user fee cover sheet: Agency opens 60-day public comment period on Form 3397, cover sheets designed to collect information to help the agency determine whether it should require a user fee for a specific drug or biologic application and the fee amount. FDA estimates in the Nov. 12 Federal Register that 200 manufacturers are subject to user fees, including 141 Center for Drug Evaluation & Research applicants...
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS087776

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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