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

Whistleblower Investigation Delayed Approval Of Forest's Savella

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA missed the user fee goal date for Forest's Savella (milnacipran) due to an investigation of late-breaking whistleblower allegations, review documents for the fibromyalgia therapy show

You may also be interested in...



Composite Endpoints In Fibromyalgia Subject Of Dueling Citizen Petitions

In trying to convince FDA to take Cypress Biosciences and Forest Laboratories' fibromyalgia drug Savella (milnacipran) off the market, the advocacy group Public Citizen has set itself the difficult task of arguing the agency out of its established policy of accepting clinical trials with composite endpoints as proof of efficacy against the disease.

PDUFA Performance In The FDAAA Era: Over One Third Of Novel 2009 CDER Approvals Took Advantage Of Relaxed User Fee Goal Interregnum

CDER met the user fee goals of almost two-thirds of new molecular entities and novel therapeutic biologics approved in 2009, even at the height of the almost two-year period when Office of New Drugs Director John Jenkins allowed reviewers to miss Prescription Drug User Fee Act action dates due to workload and resource constraints

PDUFA Performance In The FDAAA Era: Over One Third Of Novel 2009 CDER Approvals Took Advantage Of Relaxed User Fee Goal Interregnum

CDER met the user fee goals of almost two-thirds of new molecular entities and novel therapeutic biologics approved in 2009, even at the height of the almost two-year period when Office of New Drugs Director John Jenkins allowed reviewers to miss Prescription Drug User Fee Act action dates due to workload and resource constraints

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS004156

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