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 "Drug Watch" Website To Include Three Categories Of Safety Information

This article was originally published in The Pink Sheet Daily

Executive Summary

The site will reflect information about serious adverse events, patient selection and monitoring, and risk minimization procedures, an FDA draft guidance states. Manufacturers will be notified "shortly before" information about a drug is first posted; agency suggests the site's information will not be used for promotional purposes.

You may also be interested in...



CDER Abandons “Drug Watch” Program To Communicate Safety In Favor Of Asterisk

FDA issues final guidance describing its approach to communicating drug safety information, including emerging information, to the public.

CDER Abandons “Drug Watch” Program To Communicate Safety In Favor Of Asterisk

FDA issues final guidance describing its approach to communicating drug safety information, including emerging information, to the public.

MedWatch Bulletin For Physicians Under Consideration At FDA

The report would be similar to CDC’s Morbidity & Mortality Weekly Report, Deputy Commissioner Gottlieb says.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062326

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