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


Citizen Petitions Face Strict Certification Requirements Under FDA Final Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...

Biosimilars Added To FDA’s Citizen Petition Certification Program

Agency estimates it will receive 26 certifications for citizen petitions that could potentially delay biosimilar or generic applications and one certification for a petition for stay of agency action.

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

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.

FDA Will Summarily Deny Petitions Submitted Solely To Block ANDA Approvals

Draft guidance in implementation of FDAAA provision outlines how FDA will weed out and deny petitions “with a primary purpose of delaying approval of an application.”.


Latest News
See All



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