Import Safety Pilot Casts Global Net For Inspecting Drug Manufacturers
This article was originally published in The Tan Sheet
Executive Summary
The U.S. is launching a pilot program with Australia and the European Union to "spread our inspection net wider" for drug manufacturing facilities, according to Health and Human Services Secretary Michael Leavitt
You may also be interested in...
Obama Budget Links Proposed User Fees To Improving Food Safety
The nearly $260 million increase President Obama requests for FDA's food safety operations includes $75 million in new user fees
Pilot Takes Off For Inspecting API Manufacturers By U.S., Europe, Australia
FDA and its counterparts in the European Union and Australia have divided responsibilities for inspecting specific active pharmaceutical ingredient facilities in third-country locations in the next 18 months as part of a pilot to monitor more sites
FDA pilot fishes for import safety answers
Six companies and government entities will participate in phase two of an FDA pilot program to assess the impact of voluntary third-party certification on import safety, FDA announces Dec. 2. The agency will apply lessons learned from the pilot, which concerns aquacultured shrimp, to other inspection areas, such as drug manufacturing facilities (1"The Tan Sheet" July 14, 2008, p. 13). FDA says the program advances the President's Action Plan for Import Safety and elements of FDA's Food Protection Plan. The government released both plans in November 2007