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

FDA’s Temple: Better Meta-Analyses Needed Ahead Of Agency Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

Senior FDA officials call for prospective planning and transparency in meta-analysis conduct; they also discuss potential for a “refuse-to-file” type of standard for meta-analyses that don’t meet certain format and content standards worthy of agency consideration.

You may also be interested in...



Drug Safety Meta-Analyses: US FDA Emphasizes Trial Quality Over Quantity

Three years overdue, agency draft guidance seeks to inject a threshold level of rigor into meta-analyses of randomized, controlled trials to evaluate drug safety and proposes a three-tiered hierarchy of evidence against which FDA will evaluate such studies for regulatory decision-making purposes.

FDA Sets New Goal For Biosimilar, Drug Promotion Guidances

Agency plans to issue 102 new and revised draft guidances this year, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and ANDA refuse-to-receive standards.

FDA Replaces Avandia REMS Distribution Restrictions With Prescriber Training

Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075102

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