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

PDUFA VI: 'Building Trust' Is Theme Of FDA-Industry Negotiations

Executive Summary

Major achievements of latest drug user fee agreement include focus on drug development cycle, more review time and pilot programs, FDA and industry reps tell DIA meeting.

You may also be interested in...



Best Of Biosimilar Agreement: FDA, Industry Tout Written Response, Pre-Submission Meeting

FDA's Leah Christl and Amgen and Sandoz representatives discuss key achievements of BsUFA II at DIA meeting; Christl expects to see interchangeable biosimilars come to market within the next two years.

Best Of Biosimilar Agreement: FDA, Industry Tout Written Response, Pre-Submission Meeting

FDA's Leah Christl and Amgen and Sandoz representatives discuss key achievements of BsUFA II at DIA meeting; Christl expects to see interchangeable biosimilars come to market within the next two years.

Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs

GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120903

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