Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Citizen Petitions: FDA Sees Increase In Requests For Reconsideration, Serial Filings

Executive Summary

FDA is concerned that the number of citizen petitions requesting reconsideration of agency decisions, the filing of serial petitions by the same firm, and requests from non-innovator companies could delay the approval of generics.

You may also be interested in...



Citizen Petitions Seeking To Delay Product Approvals Continue To Swamp FDA

Agency's latest report to Congress highlights resource burden, implies legislative fix may better discourage frivolous petitions.

Citizen Petitions Face Strict Certification Requirements Under FDA Final Guidance

FDA will reject petitions that do not include exact language for certification and verification; hedge fund manager files citizen petition opposing approval of Neoprobe's Lymphoseek.

Citizen Petitions Face Strict Certification Requirements Under FDA Final Guidance

FDA will reject petitions that do not include exact language for certification and verification; hedge fund manager files citizen petition opposing approval of Neoprobe's Lymphoseek.

Topics

Latest News
UsernamePublicRestriction

Register

PS053109

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