FDA/EMA Bioequivalence Collaboration Is Narrow In Scope, Wide In Reach

In contrast to the existing inspection program for clinical trials, sites around the globe will be targeted.

The next component of the FDA and the European Medicines Agency cooperative clinical inspections program will be both narrower in scope and wider in reach, focusing on bioequivalence studies conducted at sites around the globe.

The two regulatory agencies announced Dec. 18 they will collaborate and share information on inspections of clinical and analytical facilities...

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