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

PhRMA Feels Deadline Pressure, Reminds FDA Of Flexibility In PDUFA Goals

Executive Summary

The Pharmaceutical Research & Manufacturers of America is suggesting that FDA can miss its user fee deadline for a product if prolonging the review would lead to swifter approval than entering a second cycle
Advertisement

Related Content

PDUFA IV Negotiations Underway With FDA, Industry Working In Harmony
PDUFA IV Negotiations Underway With FDA, Industry Working In Harmony
Phase IV Discussions Should Begin Earlier In Review Process, Wyeth Says
FDA Defines Good Review Management; No Data In Labeling Negotiations
FDA Defines Good Review Management; No Data In Labeling Negotiations
FDA NDA/BLA Early Input Letters: How Much Should Be Publicly Disclosed?
FDA Emphasizing Written Communication With Sponsors On Pending NDAs
Advertisement
UsernamePublicRestriction

Register

PS042586

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