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

FDA Actions, In Brief

Executive Summary

FDA ended the week with a flurry of activity, issuing a “complete response” letter, cancelling an advisory committee and approving several drugs.

You may also be interested in...



Regulatory News, In Brief

CDC panel recommends combined regimen of Pfizer’s Prevnar 13 and Merck’s Pneumovax 23 in immunocompromised adults; FDA issues “complete response” letters and completes review of compounded hydroxyprogesterone.

Animal Rule Studies Should Be As Well-Designed As Human Clinical Trials, Panel Says

FDA's Anti-Infective Drugs Advisory Committee unanimously said ciprofloxacin and Ortho-McNeil-Janssen Pharmaceuticals Inc.’s Levaquin (levofloxacin) had proven their efficacy for pneumonic plague in studies in African Green Monkeys, but the panel may be less willing to overlook study design flaws in less life-threatening conditions.

Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools

A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS054409

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