Generics Bulletin 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


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

Executive Summary

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.

You may also be interested in...

FDA's Generic Approvals Catch A Bit Of Breath In July But Continue At Fast Pace

US Generic drug approvals drop in July, but still are above the monthly average for the year, potentially signaling a new expected output.

FDA's Off-Patent, Off-Exclusivity List Draws Few Takers Early On

US agency has received 'very few' inquiries about the drugs on the list since its release.

Implementing User Fees Should Be Lighter Lift For FDA This Time Around; Bill Heads To White House

The 2017 user fee reauthorization bill contains provisions that should be significantly easier for the agency to implement compared with the 2012 measure. Senate clears clean bill for president's review.

Related Content


Related Companies

Latest Headlines
See All



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