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

US FDA Blood Pressure Risk Assessment Guidance Uses Unique Format

Executive Summary

As agency embraces bullet-point format, old-school draft full of call-outs and solicitations seems unlike anything before or since. Regardless of style, FDA's testing recommendations for developmental therapies are of broad, substantive interest to industry.

You may also be interested in...



How Can FDA Advance Cell Therapy R&D? Issue Guidance in ‘Real Time,’ Encourage Collaboration With Industry, CBER’s Marks Says

CBER will take a page out of the drug center’s book and start issuing shorter guidances more quickly; sponsors should also be on the lookout for an RIF on ways to collaborate with agency.

No Pressure: FDA Floats Threshold On Adverse Blood Pressure Effect In Chronic Drugs

Revised draft guidance proposes that sponsors of new drugs intended for chronic use should rule out a 3-mmHg blood pressure increase in pre-market trials.

US FDA Plans To Standardize Review Of Blood Pressure Effects Of New Drugs

Approach is modeled after the interdisciplinary review team established more than a decade ago to review data on QT interval effects, FDA says; at a recent Duke meeting on assessing off-target pressor effects, discussion focused on lessons learned in the QT space that could be applied to studying blood pressure effects.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123278

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