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 Should Have Larger Role In Trade Talks, Hamburg Says

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA commissioner believes the agency needs to have “a full place at the table,” rather than being summoned into the process late and viewed as obstructionist when it raises public health concerns.

You may also be interested in...



U.S. FDA Wary About “Paying The Price” For Mistakes Based On Foreign Data

It is going to take time for the public and policymakers to get comfortable with the idea of U.S. FDA making regulatory decisions based on information from other countries, Commissioner Hamburg says.

Foreign Regulatory Systems Can Be Strengthened By Receiving FDA Inspection Data, IOM Says

Institute of Medicine report recommends how FDA, industry and other stakeholders can strengthen food and drug regulatory systems abroad. It calls for FDA to provide incentives for foreign regulators to meet U.S. standards and facilitate training and for the government to help hold importers liable.

Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing

Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS073331

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