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

ANDAs By The Numbers: Metrics Look Good – But Review Processes Need Attention Too

Executive Summary

US FDA is approving generics at record pace, providing important statistics to support efforts by Commissioner Gottlieb to position the agency as part of the solution to concerns about high drug prices; new guidance for industry and FDA reviewers, however, suggests there is still a need for more rigor in preparing and assessing submissions.

You may also be interested in...



ANDA Complete Responses Spike In FY 2018, But Why?

In the first quarter of FY 2018, the agency issued over 800 CRs for generic drug applications, more than half the total it issued in all of FY 2017.

ANDA Complete Responses Spike In FY 2018, But Why?

In the first quarter of FY 2018, the agency issued over 800 CRs for generic drug applications, more than half the total it issued in all of FY 2017.

FDA Ends ANDA 'Reviews' To Streamline Approval Process

Instead, US agency will conduct 'assessments' of generic drug applications, according to new MaPP.

Related Content

Topics

UsernamePublicRestriction

Register

PS122289

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