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 GMP Penalties Still Include Disgorgement, Agency Official Says

Executive Summary

FDA continues to believe it has the authority to pursue disgorgement of profits in its enforcement actions, FDA Deputy Associate General Counsel Eric Blumberg said

You may also be interested in...



FDA Can Seek Disgorgement As A Remedy Under FD&C Act, Court Rules

FDA's use of the remedy of disgorgement is permitted under the Food Drug & Cosmetic Act "in appropriate cases," according to a recent court ruling by the U.S. Circuit Court of Appeals in Denver

FDA Can Seek Disgorgement As A Remedy Under FD&C Act, Court Rules

FDA's use of the remedy of disgorgement is permitted under the Food Drug & Cosmetic Act "in appropriate cases," according to a recent court ruling by the U.S. Circuit Court of Appeals in Denver

GSK Consent Decree Sets “Aggressive” 150-Day Timeline For GMP Conformity

GlaxoSmithKline's consent decree mandates that the company notify the agency within 150 days of the corrective measures it has taken or plans to take in addressing FDA's good manufacturing practice concerns

Related Content

Topics

UsernamePublicRestriction

Register

LL1135307

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