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

Generic Drug Review At US FDA: Has Submission Rush Ended Or Just Paused?

Executive Summary

Excitement to get a 10-month ANDA review may have waned in January as submissions plummet, but can approvals keep up?

You may also be interested in...



Generic Drug Review: US FDA Approves More ANDAs Than It Receives For First Time Since Early 2016

Among the 61 approvals in February appear to be ANDAs from the official GDUFA backlog, which have been pending for more than four years.

Generic Drug Review: US FDA Approves More ANDAs Than It Receives For First Time Since Early 2016

Among the 61 approvals in February appear to be ANDAs from the official GDUFA backlog, which have been pending for more than four years.

ANDA Stress Test: End-Of-Year Submission Bolus Pressures US FDA Review System

As more generic applications arrive, Office of Generic Drugs staff may have a tougher time reaching review goals.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119988

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