Russel K Statman's Articles

FDA Consulting assistance with FDA Regulations, FDA Compliance and FDA Validation
The U.S. customs and FDA work closely and recently while doing a spot examination of a mail shipment of foreign drugs, the US Customs revealed that such shipments usually contain counterfeit and unapproved drugs that create severe safety problems. This jo...

FDA Approved Products
FDA's approval process for the products it regulates, are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers. FDA aims to provide 'safe and effective' pr...

International Coordination of Food Safety Regulations
As food distribution chains are increasingly stretched around the world, urgency has arisen for the creation of new food safety standards and stricter enforcement of existing food safety laws to ensure that food industry quality control and food processin...

The United States Food and Drug Administration and NAFTA
The North American Free Trade Agreement (NAFTA) helps safeguard the ability of the United States Food and Drug Administration to ensure food safety and quality within North America. NAFTA is an agreement between Canada, the US and Mexico that took effect...

FDA Registration of Food Facilities
The US Public Health Security and Bioterrorism Preparedness and Response Act 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to receive...