Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Generic Drugs: First-Cycle Review Times Improve, But Hundreds Of ANDAs Still Pending

Executive Summary

US FDA cut first-cycle review time 46% between fiscal year 2013 and FY 2015, but more than 900 ANDAs still awaited review by end of 2016.

You may also be interested in...



Is ANDA Bolus Coming As Higher User Fees Loom?

Generic submission volume remained steady in August as some wonder whether sponsors will rush to avoid a 144% increase in the ANDA user fee taking effect Oct. 1.

Is ANDA Bolus Coming As Higher User Fees Loom?

Generic submission volume remained steady in August as some wonder whether sponsors will rush to avoid a 144% increase in the ANDA user fee taking effect Oct. 1.

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS121014

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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