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

The FDA and its Plans to Establish a Presence Overseas

This article was originally published in SRA

Executive Summary

Senior Food and Drug Administration official Murray Lumpkin talks to John Hatjoullis about how the US can no longer consider its borders to be its first line of defence against substandard imports.

You may also be interested in...



Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents

Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.

First EMA Nod For Generic Xarelto; Apotex Pulls Upkanz For Neurodegenerative Disease

While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.

US FDA Adds Hand Sanitizer Import Alert Category After COVID-19 Production Surge Turned Deadly

Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.

UsernamePublicRestriction

Register

LL1133951

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