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FDA Clarifies Worldwide Inspection Policies

from PharmTech

In the name of enhancing transparency in agency decisions and compliance actions, FDA is publishing updated information on how it selects and schedules pharmaceutical plant inspections around the world and the process for disclosing the findings of those oversight actions. The increasingly global nature of the biopharmaceutical supply chain has prompted FDA to revise its inspection process and to seek harmonization in standards for United States and foreign regulatory oversight to further ensure the safety and quality of medicines in the U.S. and around the world. more


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