Mock FDA Inspection

An innovative biopharmaceutical company focused on development and commercialization of medicines to treat renal diseases were in need of an urgent mock Food and Drug Administration (FDA) inspection.

On Novartis' Data Manipulation

The news this past week that scientists at Novartis manipulated data in comparability studies for their gene therapy (Zolgensma) was surprising and disheartening. You can read one of the 

Apple Watch Approval Marks Shift In Device Development And Approvals

In September, the U.S. Food and Drug Administration (FDA) approved the Apple Watch’s electrocardiogram feature, clearing the way for use of the watch as a medical device. This is the latest step in the FDA trying to quickly catch up with the evolution of technology available to consumers going the direction of medical devices.

FDA 483 Action Planning & Remediation

An early stage device company received a 483 with multiple observations after a long two-week BIMO inspection and were in need of strategic support to address findings in a short period of time and develop an action plan for remediation.

The life of a virtual clinical trial participant

I am currently participating in a clinical trial. I have neither seen a physician nor traveled to a site for a procedure. During my first 15 days of trial participation, my samples have been sent 43 times - and I never once had to leave my house for it.
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