Pink Sheet is part 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

FDA Warning Letters Do Not Prove Wrongdoing, Appeals Court Finds

Executive Summary

A state appeals court ruled that FDA warning letters are informal and advisory notifications and thus cannot be the basis of a finding that Johnson & Johnson made false and misleading statements to health care providers about Risperdal (risperidone) and Duragesic (fentanyl).

You may also be interested in...



Drug Literature Cases Raise First Amendment Issues

Litigation over the dissemination of scientific information at odds with FDA's instructions could define how the right to freedom of speech applies to marketing food and drug products.

Drug Literature Cases Raise First Amendment Issues

Litigation over the dissemination of scientific information at odds with FDA's instructions could define how the right to freedom of speech applies to marketing food and drug products.

FDA Standardizing “Dear Doc” Letters To Fix Problems With Recipients As Much As Senders

FDA appears to have found problems on both the senders’ and recipients’ sides of “Dear Health Care Provider Letters” and issued guidance recommending effectiveness assessments and formatting specifications in an attempt to give the correspondence more impact.

Related Content

Topics

UsernamePublicRestriction

Register

PS052878

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