FDA Should Be Allowed To Schedule Foreign Inspections Based On Risk – CDER’s Woodcock
This article was originally published in PharmAsia News
Executive Summary
Potential legislation to strengthen FDA oversight of foreign drug producers should allow the agency to target facilities and products based on risk, Center for Drug Research and Evaluation Director Janet Woodcock recommended at a May 1 House Energy and Commerce Health Subcommittee hearing
You may also be interested in...
U.S. FDA, PDA Kick Off First Conference On Quality Systems For China’s Manufacturers, Suppliers
SHANGHAI - The U.S. FDA, the Parenteral Drug Association and the respective local Chinese FDA jointly held the first education seminar on quality systems in Shanghai and Beijing in late April
U.S. FDA, PDA Kick Off First Conference On Quality Systems For China’s Manufacturers, Suppliers
SHANGHAI - The U.S. FDA, the Parenteral Drug Association and the respective local Chinese FDA jointly held the first education seminar on quality systems in Shanghai and Beijing in late April
U.S. FDA’s Poor Performance ‘Invites Catastrophe’ – U.S. Congressional Committee On Heparin Investigation
The House Energy & Commerce Subcommittee on Oversight and Investigations simultaneously lauded and criticized U.S. FDA's handling of the heparin contaminant safety issue, which FDA now says was most likely the result of intentional actions