Scrip 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

US/EU Avandia decisions varied because of "toolbox", says FDA expert

This article was originally published in Scrip

Executive Summary

Pharmaceutical companies wanting to learn more on how different decisions are made by different regulatory agencies on their products (while using the same data) should take notice of one expert with the FDA. It seems it relies on the tools available to regulators.

You may also be interested in...



US FDA head Hamburg declares no one can inspect world on its own

The US Food and Drug Administration recently signalled its desire to work more closely with other drug regulators in assessing the quality of pharmaceutical manufacturing facilities around the world.

FDA's Hamburg declares no one can "inspect world on its own" for poor quality medicines

It seems as if the US FDA is softening its stance on assessing the quality of pharmaceutical manufacturing facilities around the world in future, with an apparent desire to work more closely with other drug regulators. However, incorporating the regulators from countries such as India, China and Japan into a global inspectorate still looks problematical.

Pharma and MSF agree on competition for cheap vaccines, but differ on pricing

Large pharmaceutical companies and Médecins sans Frontières may not often see eye-to-eye over access to medicines in poor countries. But it seems as if industry and the humanitarian body, a prominent critic, do agree that competition works in improving access to vaccines, even though they don't agree about the mechanisms of price setting.

Topics

Related Companies

UsernamePublicRestriction

Register

SC010414

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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