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

Nuplazid's Black Box: Warning May Depend On Antipsychotic Classification

Executive Summary

Advisory committee questions whether an antipsychotic drug class boxed warning should go in the Nuplazid label if it is approved; some debate whether the product is part of that class.

You may also be interested in...



Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire

Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.

Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director

Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.

CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings

FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS057548

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