The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...

WASHINGTON, Jan. 20, 2026 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in clinical trials, formally recognizing ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.