Karim Mikhail

Stories

FDA launches pilot to speed up early-stage drug trials

Co-leads the pilot from the biologics center

A first-in-human drug trial can take up to two years to complete in the United States. The FDA's pilot, part of Operation TrialBlazer, tests a faster path to starting such trials by having sponsors partner with research institutions while the agency reviews application pieces as they are finished.

Updated Oct 4

FDA licenses first US freeze-dried plasma product

New Capabilities

Oversaw the Ezplaz licensure

For decades, US plasma transfusions required a freezer and time to thaw. Ezplaz, the first US-licensed freeze-dried plasma, reconstitutes in about 2.5 minutes and sits on a shelf for a year.

Updated Sep 1

Notable Quotes

The FDA is doing our part to ensure American patients continue to receive access to therapies first, while keeping scientific innovation and investment in America.

from FDA launches pilot to speed up early-stage drug trials · Updated Oct 4

On austere settings: "Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable."

from FDA licenses first US freeze-dried plasma product · Updated Sep 1