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

Evolution In Clinical Outcome Assessments Reflected In US FDA’s Revised Gastroparesis Guidance

Executive Summary

Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.

You may also be interested in...



Keeping Track Of US FDA Decisions: COVID-Induced Complete Response Letter For Contepo; Safety Sinks Abicipar Pegol; Approvals For Fintepla and Gimoti

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track: Industry Channels Inner Gottlieb As Commissioner Departs US FDA

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Targets Migraine, Schizophrenia And Opioid Sparing Drugs For Clinical Outcome Assessment Development

Grant solicitation, a different approach than agency has so far taken with biomarkers, signals growing importance of patient input in drug development.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS140842

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