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2024/02/16 AD Regulation-related Trends/Others
2023/12/15 AD Regulation-related Trends/Others
FDA's Criticized Overseas Inspection Program
The U.S. House of Representatives Committee on Energy and Commerce oversees the FDA's foreign drug inspection program. Members of the Committee h
2023/11/17 AD Regulation-related Trends/Others
2023/10/20 AD Regulation-related Trends/Others
2023/04/07 AD Regulation-related Trends/Others
Some Considerations about Process Validation
When the FDA first introduced the concept of process validation in 1987, it defined process validation as "Establishing documented evidence which