Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

Data governance, data integrity, and data quality are all widely used terms, but what do they actually mean and how are they connected? Nomenclature is important. Data governance, data integrity, and ...

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications. On April 1, 2024, ...