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

ANDA Application Backlogs, Submission Bubbles Plague User Fee Rollout

Executive Summary

FDA says in its first GDUFA performance report to Congress that it met all statutory requirements in fiscal year 2013, but while the agency worked on several FY 2013 applications, it did not approve an original ANDA submitted that year.

You may also be interested in...



FDA Generics Office Hopes To Clear Unmeasured ANDAs

The U.S. FDA’s Office of Generic Drugs restructures again and adds specialist who helped relieve supplement backlog to improve ANDA review process.

Backlog Backfire: FDA Sees Increase In Pending Generic Applications At Deadline

The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.

Drug Review Times Are Not Shortened Much By Single Expedited Review Designation

Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.

Topics

UsernamePublicRestriction

Register

PS055930

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