Foreign Regulatory Systems Can Be Strengthened By Receiving U.S. FDA Inspection Data, IOM Says
This article was originally published in PharmAsia News
Institute of Medicine report recommends how U.S. 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.
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The agency still plans to move forward with coalition-building and increased data-sharing aspects of globalization initiative.
Agency wants to target supply-chain threats and help judge the value of information received from third-party inspections.
In Wake Of Heparin Deaths, FDA Set To Launch Pilot Project Aimed At Preventing Imports Of Adulterated Drugs
BEIJING - One year after adulterated heparin sourced from China began triggering scores of adverse reactions and deaths in U.S. patients, U.S. FDA is preparing to launch a voluntary pilot program aimed at helping prevent contaminated drugs from entering the country