FDA

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...

It is Game On! at Commissioner Scott Gottlieb's U.S. Food and Drug Administration.

Recognizing the FDA lacks a direct role in drug pricing, his overarching strategy is to facilitate increasing market competition so as to drive down prices-- thereby increasing accessibility and innovation (see details of his Drug Competition Action Plan here). His parallel focus to achieve these goals is to curb abuses of the Orphan Drug Act (ODA). 

President Reagan signed the Orphan Drug Act in 1983 in an attempt to incentivize discovery. Smaller population ...

Bacteria that are resistant to one, multiple or even all known antibiotics, commonly known as superbugs, are one of the leading concerns in the medical and scientific communities. 

With the traditional methods of combating bacterial infections not working - alternative ways to stop the infections from starting or, at least, from spreading - are necessary. This would mean cutting down on the number of infections and because many of these infections are nosocomial (acquired while someone is staying in the hospital) spread through the use of contaminated instruments - clean instruments are an imperative first step to stop the bacteria's spread. 

But, many medical devices are incredibly difficult to clean well enough to stop the spread of bacteria. They may have hard to reach...

For some time, we have been covering the investigation into the practices used to produce the homeopathic teething products that allegedly caused illnesses and deaths of infants. Most recently, we wrote about a warning letter sent from FDA to Raritan Pharmaceuticals - one of the companies that sold the products - that listed multiple violations found in their facility. 

A letter was also sent to Homeolab - the Canadian company that manufactures the powder blend mixtures that are used by Raritan for making the teething products. As a result of an inspection, significant violations were found at the site.  

The most important violations concerned...

The cancer drug business is quite a profitable one. A “high risk, high reward” proposition has been the narrative for those in research and development (R&D). Successes, marketing, patent protection and discovery cost money. Failures cost money. Not pursuing a different path with a failure or even a success costs money. As does lost revenue while performing R&D. 

Can an accurate dollar value even be placed on what it takes from idea conception through utilization to develop a new drug? Due to the opaque nature of the industry’s disclosures, a new study published in JAMA Internal Medicine sought to quantify a standard amount by focusing on new cancer drugs and analyzing the...

When it comes to cancer breakthroughs, there have not been many announcements as big as the one made this week by the U.S. Food and Drug Administration - the approval of the first gene therapy for cancer available in the United States. 

The approved drug, made by Novartis, is called Kymriah (tisagenlecleucel) and is used to treat certain pediatric and young adult patients with a form of B-cell acute lymphoblastic leukemia (ALL). The approval is for patients up to 25 years old, with ALL that has resisted standard treatment or relapsed (roughly 15 - 20 percent of patients.) ALL is leukemia - a cancer of the bone marrow and blood. it is the most common form of cancer that affects...