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 To Facilitate 4-AP Compassionate Use INDs For MS, Axelrad Says

Executive Summary

FDA will ensure that multiple sclerosis patients taking 4-aminopyridine will continue to have the unapproved drug available through compassionate use INDs, Associate Director-Policy Jane Axelrad told the Pharmacy Compounding Advisory Committee July 14.

You may also be interested in...



Catalyst Stumbles With Filing Of Controversial 'Breakthrough Therapy' Firdapse

FDA’s refuse-to-file letter for Firdapse in two ultra-rare neuromuscular disorders does not make judgments about the drug’s safety or efficacy, says Catalyst.

In With The Old? 2013 To Mark Rebirth Of CDER’s Pharmacy Compounding, Medical Imaging AdComms

FDA has signaled that it will re-form its Pharmacy Compounding Drugs Advisory Committee, which was dissolved in 2002, as it deals with an ongoing meningitis outbreak related to compounded steroid injections. 2012 proved to be another busy year for the Oncologic Drugs Advisory Committee, but the full drug safety/risk management panel saw a significantly lighter workload than in recent years.

FDA’s Advisory Committee Schedule Hints At Re-formulated Compounding Panel

The agency has not set a meeting date for the Pharmacy Compounding Drugs Advisory Committee, defunct since 2002, in its tentative schedule, but has included 13 vacancies on the panel in its list of committees in need of new members.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS036372

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