Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

Late-Cycle Meeting: The PDUFA V Goal Letter

This article was originally published in RPM Report

Executive Summary

The following text is the description of the late-cycle meeting in the “goal letter” negotiated by FDA and the pharmaceutical industry in advance of the Prescription Drug User Fee Act reauthorization.

You may also be interested in...



US FDA’s Inner Circle Takes Shape: Shah Seen As Potential Successor To Abernethy

Anand Shah returns to FDA as deputy commissioner; like Abernethy, he is an oncologist with a background in big data.

‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA

Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.

US FDA’s End-Of Year Approval ‘Rush’ And Other Criticisms: Fact Or Fiction?

FDA has been criticized in recent months for approving drugs too quickly, based on insufficient evidence. The agency’s oncology chief Richard Pazdur fights back.

Topics

UsernamePublicRestriction

Register

PS081088

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