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

Shutdown Week Four: FDA Maintains Pre-Shutdown Output Pace In Some Cases

Executive Summary

ANDA and NDA/BLA supplement approvals continue thanks to carryover user fee funds, but US FDA hasn't made any NDA and BLA approvals during shutdown as as anxiety over effect of "lapse period" on agency increases.

You may also be interested in...



US FDA Not Changing Assessment Goals Because of Coronavirus-Mandated Telework

Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.

US FDA Appears To Have Avoided Shutdown-Related ANDA Bolus

Generic submissions were below historical norms in December and modestly higher January, meaning shutdown likely did not create a large pile of pending work.

ANDA Review: Moving From Tentative To Final Approval Could Require 10 Months Or More

US FDA draft guidance says substantive changes to reference product may require major ANDA amendment and 10-month review goal for the generic.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124556

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