Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Drug Safety Concerns Could Affect Early Review Stages, FDA's Gottlieb Says

This article was originally published in The Pink Sheet Daily

Executive Summary

The deputy commissioner reiterates that the agency has not become risk averse when it comes to approvals, however.
Advertisement

Related Content

FDA List Of Potential Safety Signals Has 3 Pfizer Drugs, Echoes Drug Watch Site
FDA List Of Potential Safety Signals Has 3 Pfizer Drugs, Echoes Drug Watch Site
CDER Abandons “Drug Watch” Program To Communicate Safety In Favor Of Asterisk
CDER Abandons “Drug Watch” Program To Communicate Safety In Favor Of Asterisk
Natrecor Concerns Are Limiting Use Of Other IV Vasoactive Therapies As Well, JAMA Finds
Natrecor Concerns Are Limiting Use Of Other IV Vasoactive Therapies As Well, JAMA Finds
Lamictal Pregnancy Monitoring Will Continue Following “FDA Alert”
Increased Safety Concerns Could Reduce Drug Development Pipelines By 20%, IMS Says
Increased Safety Concerns Could Reduce Drug Development Pipelines By 20%, IMS Says
FDA “Drug Watch” Early Warnings Will Have Lasting Negative Effect, PhRMA Says

Topics

Advertisement
UsernamePublicRestriction

Register

PS064833

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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