Katrina’s Blog™

Earlier this year, the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The...

The FDA’s Center for Devices and Radiological Health (CDRH) is reorganizing this year to better integrate the center’s premarket and postmarket program functions and optimize decision making across the total life cycle of medical devices. The new organization will be...

The FDA’s Oncology Center of Excellence (OCE) in cooperation with CDER and CBER has released several new guidances intended to broaden the eligibility criteria for cancer clinical trials. A trial’s eligibility criteria define the patient population studied in the...

This February CDER issued draft guidance for clinical studies on the effects of food administration on and bioavailability of orally administered drug products. The bioavailability guidance also applies to drug products where systemic exposure measurements are...

Combination products are medical products composed of 2 or more different types of individual medical products; for example, a drug plus dosing device (think of asthma inhalers or prefilled syringes) or a drug plus the solution needed to reconstitute it for dosing...