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


ANDA backlog

Executive Summary

Plan to unblock ANDA review jam will be considered at a Center for Drug Evaluation and Research meeting on Sept. 17. A center plan could issue as early as the end of the week. At an FDA chemists' "retreat" in Harpers Ferry, West Virginia, on Sept. 6 and 7, CDER Director Peck charged the center's chemists with devising a plan to eliminate the backlog of ANDAs. At the conference, Peck suggested that a possible strategy might be to assign several ANDAs a month to new drug evaluation divisions, or, alternatively, send more NDA reviewers to review ANDAs in the Generics Division.



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