Consumer wearable and smartphone devices provide an accessible means to objectively measure physical activity (PA) through step counts. With the increasing proliferation of this technology, consumers, ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

The Centers for Medicare and Medicaid Services recently sent shudders through the specialty drug market by authorizing Medicare Advantage Plans to use step therapy protocols for Part B drugs. The ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...