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, EMEA To Hold Joint Scientific Advice Meetings With Sponsors

This article was originally published in The Pink Sheet Daily

Executive Summary

One-year pilot program will launch in January to address specific development issues for breakthrough products. Meetings will provide an "opportunity to optimize product development" and are expected to help avoid unnecessary replication or divergence in agency methodologies, FDA and EMEA say.

You may also be interested in...



EMEA Projects Drug Applications Will Double In 2006

Agency is unclear why applications are up, but notes that, unlike last year, there have been generic and biosimiliar applications.

EMEA Projects Drug Applications Will Double In 2006

Agency is unclear why applications are up, but notes that, unlike last year, there have been generic and biosimiliar applications.

Biogen Idec Assumes Aviptadil Development Responsibility From Mondobiotech

Phase III product would join a growing pulmonary arterial hypertension market.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS058557

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