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

Not So Fast On Expedited Approvals, Drug Safety Researchers Caution

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Analysis finds that expedited pathways – priority review, accelerated approval and fast track status – bring drugs to market faster, but cautions that pushing safety evaluation to the post-marketing setting carries its own risks, JAMA Internal Medicine article finds.

You may also be interested in...



Pivotal Studies Supporting US FDA Drug Approvals Have Declined, JAMA Research Finds

Over 30-year period, approvals increasingly used expedited programs and were based on fewer pivotal trials with less robust comparators, authors report.

Safety Events For Accelerated Approval Drugs Highlighted As Expansion Looms

US drugs with accelerated approval are more likely to experience a postmarket safety event, JAMA study finds; data sharing could be a solution to filling information gaps.

What Innovation Crisis? First-In-Class Drug Approvals Stable For Almost 25 Years, FDA Says

An FDA study evaluating NMEs by level of innovation finds level first-in-class approvals to be consistent, and approvals after the study period reinforce “encouraging” findings. Analysis says new metric should be basis for assessment of programs created by FDASIA to speed development of innovative products.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS005291

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