FDA

Let the games begin. With an announcement just made by Intermountain Health, it appears the organization will be leading a multi-system collaborative effort, which controls 450 U.S. hospitals, in making a strategic play in the generic drug market. The stated goal: to reduce drug shortages and lower prices.

Before we delve further into this seemingly disruptive move, a little background is necessary. As of late, the pharmaceutical industry has been much maligned in a very high profile way, in particular throughout the presidential election as a target of blame for rising health care costs and continuing to reach a national stage...

Homeopathic treatments can be bought almost everywhere. They're the ones that are likely labeled as "natural remedies" and have pictures of grass or leaves on them. What they don't have on them is a label that says "FDA approved", which has been the case since 1988.

However, it may be that that is about to change. 

The US Food and Drug Administration (FDA) announced earlier this week that it is going to start to crack down on some homeopathic products. This statement is almost three years in the making since they announced in early 2015 that they were considering changing their stance on homeopathic regulation. Now, a new, risk-based enforcement approach has been announced. 

The plan is not going to concern itself with all homeopathic products. The new policy will...

Recently, I had the pleasure of filming a segment on the top medical, science and technology innovations of 2017 at Reuters TV in Times Square, New York with host of CCTV Bianca Chen (video clip forthcoming).

It was an exciting year in the pursuit of the once impossible when it comes to medical developments. Here are some top picks that genuinely are changing the landscape:

1) Cancer

Immunotherapy takes the top spot as personalized treatments approach cancer cure in a whole new way. This year, there has been success in its use in leukemia and lymphoma, and now solid tumors are being added to the slate. Time will tell if the latter group will yield similar promising results. Though in its relative infancy, the achievements are being...

Nothing elicits a surge in my skeptic meter like the term world-renowned when used in the medical realm. Especially since it is typically self-described by those selling something, routinely an unnecessary product or procedure.

Those who are authentically world-renowned, who are the real deal, rarely boast about it. Shameless self-promotion is a tough thing for the more earnest medical and science professionals. With the ever-increasing competition today, striking the balance so as to garner enough interest in their work so they can pursue what they so incredibly cherish is often an unnatural road.

Being exactly who you say you are, nothing more and nothing less, reflects the best there is in medicine. This way of navigating the profession prioritizes patient...

From CAR-T cancer therapy to the power of CRISPR-Cas9, the recent advancements in gene therapy are astounding. For a particularly impressive example, please read the story of how scientists created a new skin for a dying boy.

The floodgates of gene therapy have opened and the promise of therapies coming down the pike is beyond exciting. New gene-based treatments are being developed that could change the course of cancer and other genetic, infectious, and other diseases.

That said, like most things, there is a time and a place for new developments to be implemented. And, the place to edit genes is not in your living room according to the US Food and...

Is the Wild West of stem cell therapies coming to an end? Newly released guidelines from the U.S. Food and Drug Administration (FDA) suggest illegitimate, unproven uses might become a thing of the past.

The latest statement by the FDA announces “a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.”

Stem cell treatments have held great promise for a few decades now. Though specific therapies in the narrow realm of blood cancers and disorders, for example, demonstrate some realized dreams as a product of bona...

In an effort to combat patient non-compliance with medications, the FDA just approved the first pill with an ingestible tracking sensor. But, will it be used for good or evil? The old proverb the road to hell is paved with good intentions comes to mind.

Improper medication use is a real problem, particularly in the realm of chronic disease. Medication mistakes outside of a healthcare facility are on the rise and resulting in serious outcomes—with home locations leading the pack. According to a new study that tracked unintentional therapeutic pharmaceutical errors and...

You can hardly buy a food product these days without seeing a claim that some food or ingredient in the product somehow benefits health. One of these has been that consuming soy protein could help decrease the risk of heart disease. Before a manufacturer can make such a claim, the FDA has to approve it, based on scientific evidence.

But now, the FDA is considering revoking the rule that allows manufacturers to make that claim. Writing for the agency, Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, explained:

"[S]ome studies, published after the FDA authorized the health claim, show inconsistent findings concerning the ability of soy...

It is hard to know what gadgets for your new baby are useful, which are unnecessary and which are actually harmful. 

There are so many gizmos out there from diaper genies to video monitors to an endless list of things to attach to your stroller. But, perhaps the most tantalizing market for new parents is that of helping your baby sleep. 

Who doesn't want their baby (and themselves) to get a good night's sleep? And, who doesn't think that $39.99 is worth seven straight hours of shut eye? 

There are many products on the market to help make that happen but they are not all safe. Now, the United States Food and Drug Administration (FDA) is cracking down on one of these sleeping products - the sleep positioner.

There are two commonly sold types of sleep...

Warning letters by the United States Food and Drug Administration (FDA) can be interesting to read. A recent one, from the end of September, is more interesting than most.

The facilities of Nashoba Brook Bakery, located in Concord, MA, were inspected by the FDA and a number of violations were found and documented. Actually, to be clear, Nashoba Brook Bakery was found to be - in one phrase - a hot mess. 

Here, we summarize some of the many (many) findings in the warning letter from the FDA. They range from cleanliness and sanitation to bugs...