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


Scrutiny Urged For FDA Divisions With High Number Of Delayed Postmarketing Studies

Executive Summary

Postmarketing studies are more likely to be delayed in some Center for Drug Evaluation and Research review divisions than others, and one of FDA’s consultants wants the agency to find out why.

You may also be interested in...

FDA Clearing Backlog Of Post-Marketing Studies, But Progress May Slow

While more than half of the post-marketing commitment backlog from 2007 and earlier has been cleared from FDA’s books, but the portion of “delayed” studies has remained consistent.

FDA Database Clean-Up Causes Jump In "Concluded" Postmarketing Studies

A more than two-fold increase in the number of concluded study requirements and commitments in fiscal 2009 appears largely attributable to a consulting firm's clean-up of FDA's postmarketing obligations database.

Office Of New Drugs Reorganization Should Better Balance Workload, FDA Says

CDER's Office of New Drugs reorganizes as rheumatology moves from analgesics to join allergy.

Related Content





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