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


FDA to provide guidances on how to appeal rejected applications -- CDER'S Woodcock.

This article was originally published in The Tan Sheet

Executive Summary

FDA TO INCLUDE APPEALS GUIDANCES WITH REJECTED DRUG APPLICATIONS, Center for Drug Evaluation & Research Director Janet Wood-cock, MD, reported at a Nov. 9 Food & Drug Law Institute/FDA-sponsored video conference. Responding to industry complaints that companies do not "know how to appeal" agency decisions, CDER will append to rejected NDAs and INDs "some general information on how to appeal and what your rights are," Woodcock explained.





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