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

Drug Sponsors Are On Schedule With Most Post-Approval Studies

Executive Summary

US FDA's Gottlieb touts use of real world evidence as report shows vast majority of postmarketing requirements and commitments progressing on schedule.

You may also be interested in...



Sponsors Staying On Schedule With Postmarketing Requirements And Commitments

About 80% of drug sponsors were on track with post approval studies in FY 2017, US Food and Drug Administration notes in its annual report on performance of applicants.

Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020

US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.

Postmarketing Commitments: Sponsors Often Do Not Publish Results Of New Clinical Trials

Only 15% of postmarketing commitments for drugs approved in 2009-2012 were for clinical trials and only half of these were published, study finds; authors call for US FDA to provide more trial information.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124272

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