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

Drug Pricing Panacea Or Just PR Victory? Expedited ANDAs May Have Limited Impact

Executive Summary

In theory, reviewing generic applications faster should speed competition; in practice, FDA's new policy likely won't make too much difference.

You may also be interested in...



Mylan Suggests Downside To FDA's Efforts To Improve Generic Drug Review

Company says that while FDA has focused on expediting approval of third and fourth generics, it has not done so for first generics and complex products.

Mylan Suggests Downside To FDA's Efforts To Improve Generic Drug Review

Company says that while FDA has focused on expediting approval of third and fourth generics, it has not done so for first generics and complex products.

Generic Drug Market Has Gaps, FDA Tells Firms In Solicitation For ANDAs

US agency unveils plans to speed reviews of generic applications in areas with limited competition and offers a list of potential targets, but threat to brands may be limited.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS057529

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