FDA

The Trump Administration recently issued two executive orders relating to biomedical science. The first involved the regulation of biotechnology products; the second involved transparency in healthcare costs. We believe both are a step in the right direction.
Recently, the FDA met to discuss CBD, the non-psychoactive component of marijuana. It made us realize that we'd never really considered the definition of a drug. Any process involving lawyers hinges on the meaning of words, so what actually does the FDA regulate?
Dr. Henry Miller, a former FDA deputy commissioner, used to be a big fan of the New York Times' coverage of science and medicine. But no longer. He takes issue with an editorial that accuses the agency of reducing its scrutiny of new drugs. Dr. Miller explains why the Times is off-base: the development of precision medicine.
The FDA is supposed to regulate absence claims. But when it comes to GMO absence claims, the FDA has done absolutely nothing. That may be about to change.
Honey doesn't treat erectile dysfunction. If it does, it might be spiked with Viagra.
These smaller population “Orphan Diseases,” defined as those that affect less than 200,000 people across the U.S., collectively impact 25 million Americans. This substantial public health issue warrants Lancet's call-to-action.
The FDA has recalled medicine used to control blood pressure because it contains contaminants that might be carcinogenic. In the quest for more profit, a Chinese manufacturer broke the rules, thinking the ends justified the means.
The FDA's current regulatory framework is out of whack -- and it comes at the expense of patient safety. The Wild West of "stem cell" clinics continues. This time, patients are hospitalized with blood infections to spinal abscesses.
The FDA and 23andMe announced a newly approved report on consumer's individual ability to metabolize commonly used medications. What a treat! But the trick was that it has, at this point, no clinical value.
Did you know if you had a cardiac arrest, the decision to give you a potentially life-saving medication or placebo – in the fleeting moment where seconds matter – might be made at random by those coordinating a study? A little-known FDA exemption allows for it.
Food labels serve one purpose, and one purpose only: To provide nutritional information to consumers. The process by which a food is produced is not relevant to its nutritional content or safety profile. Therefore, products made using animal cell culture techniques absolutely should not require special labeling.
The gloves are off in a battle to control the sector. Nearly 83% of hospitals are charging over twice the cost for medicines, with a majority of mark-ups between 200 and 400%. Will any fixes in store actually help patients?