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

ANDAs Showing Steady Improvement In First-Cycle Approval Times

Executive Summary

First-cycle approvals took longer than multi-cycle approvals in the generic drug user fee program's first year, but decreased dramatically in year two.

You may also be interested in...



Candidates For The US FDA’s STAR Program Might As Well Be Breakthrough Therapies, Too

The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.

US FDA Likely To Embrace In-Person, Remote Combo For Facility Inspections Going Forward

System likely will evolve as post-pandemic world unfolds, but adds to list of agency programs expecting to continue using virtual platforms once in-person activities are no longer restricted by COVID-19.

US FDA Likely To Embrace In-Person, Remote Combo For Facility Inspections Going Forward

 

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS057562

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