POSTS TAGGED AS FDA

Digital Health Devices in Clinical Trials

Digital devices and clinical trials J
Five issues confront digital devices moving into clinical practice: usability, accuracy, safety, convenience, ease of [MORE]

Stem Cell Cosmetology, or How to Grow Bones in Your Eyes

Stem Cells for Cosmetic Surgery
Regenerative medicine holds many wonders, but not without worries too.  This piece tells how plastic surgeons [MORE]

Soup to Nuts for Innovators

In a new handbook that guides innovators through a process from discovery to the marketplace, Richard J. McMurtrey, M. [MORE]

For Toxicity Testing, a Human-Body-on-a-Chip

Over the next five years, the National Institutes of Health, the Defense Advanced Research Projects Agency (DARPA) and the [MORE]

Instant Coffee: Who Knew?

Tagline rarely includes news about drugs, much less nutritional supplements, but this piece-an FDA warning about Magic Power Coffee, [MORE]

FDA Reviews Infusion Pump Risks

The infusion pump is a ubiquitous piece of hospital equipment, often at a 3:1 ratio to the number of [MORE]

Analytics for Medical Device Clinical Trials

The FDA recently issued guidelines for using Bayesian statistical methods to correlate data from current and earlier clinical trials [MORE]

Device Advice

There aren’t many, if any, better sources of information about medical devices than the FDA’s website “Device Advice.”  It gives [MORE]

Patenting “Biosimilars”

Several bills now in Congress could result in a fundamental change to patenting biologics (such as monoclonal antibodies).  One bill [MORE]

FDA Approves First Drug from Genetically Engineered Animal

The FDA has approved GTC Biotherapeutics’ (Framingham, MA) antithrombin alpha from genetically engineered goats.  For more than a decade, recombinant [MORE]

FDA Policy on Class III Devices

The Obama administration likely will have the FDA review its approval processes for all Class III medical devices (i.e. those [MORE]

FDA Approved Five More i-STAT Tests

Abbott’s i-STAT handheld blood analyzer has just received an FDA waiver for five more tests using its 18 cartridges, which [MORE]

Designing Drug-Eluting Stents

Stent
There are currently only four drug-eluting stents under FDA approval, and their effectiveness or ineffectiveness have been called into question.  [MORE]

Clinical Trial Participation

With a noticeable shift from small molecules to biologicals, it’s no surprise that The Philadelphia Business Journal reports that biopharma [MORE]