Blog
Building expertise and crossing boundaries to improve oversight
By Howard Sklamberg, J.D.
As FDA’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee FDA’s efforts to further advance its thinking and strategies from a primarily domestic to a globally focused regulator.
Duchenne muscular dystrophy: The decade of therapy
Johns Hopkins and UCSF-Stanford join FDA’s Centers of Excellence in Regulatory Science and Innovation
By Dr. Stephen M. Ostroff
If you’ve been following my blog series about the Office of the Chief Scientist (OCS), you know about a critical component of nearly all FDA efforts to promote innovative approaches to developing and evaluating our regulated products – collaboration! This week FDA made two new additions to its network of academic partnerships known as Centers of Excellence in Regulatory Science and Innovation (CERSIs).
‘Heart on a chip’ suggests a surprising treatment for a rare genetic disease
Caffeine helps premature babies breathe a little easier…but how much and for how long?
By Tom Ulrich
The caffeine in coffee might help get you going in the morning, but for premature babies it can be lifesaving. For more than a decade neonatologists have routinely given premature newborns caffeine as a respiratory stimulant, helping their immature lungs and brains remember to breathe and reducing episodes of intermittent hypoxia (IH)—short, repetitive drops in blood oxygen levels.
Artifacts tell the story of our culture and FDA’s history
By John Swann, Ph.D.
Direct-to-consumer genetic testing: a case of potential harm
Last November, the U.S. Food and Drug Administration issued a “cease and desist” order to 23andMe, a major purveyor of direct-to-consumer (DTC) genetic testing. In its letter to the company—issued after three prior warnings—the FDA reiterated its view that 23andMe’s Personal Genome Service (PGS) constitutes a medical device requiring further premarket evaluation:
Hearing restoration has a sound future
By Jeffrey Holt
Strong review performance brings innovative medical products to patients
By Margaret A. Hamburg, M.D.
There are many ways FDA supports biomedical innovation as part of our mission to protect and promote public health. We are committed to finding ways to ensure that safe and effective products can get to the people who need them as swiftly as possible. With that in mind, we were pleased with new data in two reports, one looking at FDA’s review performance for prescription drugs, the other for medical devices.
Capturing complexity: Modeling bone marrow on a chip
By Tom Ulrich