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

ANDA Review Consistency Could Emerge As A GDUFA Problem

Executive Summary

Industry officials are concerned all the new FDA hires to handle generic drug user fee program issues will lead to varied interpretations of agency policy and potentially create first-to-file or other problems.

You may also be interested in...



Gottlieb Highlights Drawback To Increasing FDA Salaries: Resource Disparity

FDA commissioner tells agency stakeholders that there could be intra-agency moves to centers and offices that can offer higher pay.

Gottlieb Highlights Drawback To Increasing US FDA Salaries: Resource Disparity

Commissioner tells agency stakeholders that there could be intra-agency moves to centers and offices that can offer higher pay.

Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA

After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.

Topics

Related Companies

UsernamePublicRestriction

Register

PS055834

Ask The Analyst

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

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