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.

Originally published on LinkedIn.

Written by Kimberlee Raymer, Joanne LaValle, and Claudia Fehling.

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.

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.

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.

The Cures Act is part of a broader effort by FDA to improve the regulatory process and speed treatments to those in need.  Dr. Gottlieb published a blog post affirming FDA’s commitment to hiring staff and meeting the goals of HHS Secretary’s Reimagine FDA directive.

When the FDA bestows an “orphan” designation, it validates a product’s potential benefit. However, sponsors can pursue and receive an orphan designation for a pediatric population which waives Pediatric Research Equity Act (PREA) requirements and exempts the product from clinical studies in a pediatric population.

Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially...