HBW Insight 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

Senate Bill Adds Criminal Liability To Global Drug Safety Enforcement

This article was originally published in The Tan Sheet

Executive Summary

A senior drug company officer or director would be required to certify the veracity of product applications and safety submissions to FDA under Sens. Edward Kennedy and Chuck Grassley's bill to improve safety in global drug manufacturing and distribution

You may also be interested in...



Senate Bill Expands FDA's OTC Manufacturing Oversight

Legislation introduced in the Senate to give FDA mandatory recall authority for all drugs would bar the agency from considering a drug's prescription status when assessing risk to prioritize inspections

Globalization Act’s Drug Safety Provisions Look Harmful For Industry

The FDA Globalization Act could be devastating to the drug industry while not creating the safety improvements that Congress expects, according to former FDA attorneys

FDA Ups Foreign Inspections In Fiscal 07; Visits 11% Of Establishments

Data from a Government Accountability Office report suggest FDA took to heart criticism of its procedures for inspecting foreign drug manufacturers, but is struggling to improve performance given financial pressures

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

RS137443

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