FDA

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...

Homeopathic products look just like the medicines they are placed next to on the shelves. However, when it comes to how these products are made - they are vastly different.

This is being brought to center stage through an investigation by FDA into Raritan Pharmaceuticals. If that name sounds familiar, it's because they are one of the companies involved in the homeopathic teething products scandal that allegedly resulted in the illnesses and deaths of infants.

The inspections resulted in two warning letters sent to the company. 

The first warning letter, sent on June 20 of this year, was to Raritan Pharmaceuticals. During an inspection of their facility in ...

Who among us hasn’t chuckled at a television prescription drug ad when it ventures into a litany of wide-ranging potential side effects like anal leakage to erections lasting more than four hours? Whether it be for depression, your heart or arthritic conditions, the major and minor adverse consequences of these advertised drugs often get promoted in ways that pose equivalent risk—this routinely does not reflect reality. 

With direct-to-consumer (DTC) ease of communication access today, product overstatements of health benefits with simultaneous minimization of possible harms has become the norm for such companies marketing to the public. The ability to do so wasn’t always the case. With such an evolution, for better or worse, has come cultural conflicts. And, now the...

Just because you did something once last year in Mexico does not mean you can do it here. That is the message the US Food and Drug Administration (FDA) is sending to a physician in New York.

Dr. John Zhang runs the New Hope Fertility Center. The center, located in a high rent district of Manhattan, is in the business of infertility treatments which are generally not a problem. It is, specifically, fertility treatments using mitochondrial DNA (mtDNA) replacement therapy (MRT) that were banned. Dr. Zhang started marketing this type of treatment through the website of his company Darwin Life (the website was not available at the time of this writing.)

These procedures are intended to allow women with heritable diseases caused by...

Under the new director, Dr. Scott Gottlieb, the Food and Drug Administration just announced a new "comprehensive regulatory plan" to decrease the plague of tobacco-related deaths. While we're pleased to see the FDA continue to pay attention to this totally preventable cause of death, we're not sure that the steps they've outlined will all be effective in doing so.

One of the more questionable aspects of the new plan is the possible encouragement of producing cigarettes with lower nicotine levels as a way to make them less addictive. While we certainly agree that nicotine is highly...

The FDA has been busy lately, from protecting children from fake autism treatments to putting enough pressure on the makers of homeopathic teething remedies to result in a recall of the products.

But the agency does not intend to stop there. It is now cracking down on the use of opioid-containing drugs for children. But, is this an overreaction? Maybe.

The FDA has restricted the use of prescription pain and cough medicines with codeine or tramadol (for pain) for children and breastfeeding mothers. They want to remind health care professionals that tramadol (1)...

The Food and Drug Administration (FDA) has updated its 'consumer update' this month, which happens to be Autism Awareness month, to bring attention to the useless autism treatments that are targeted towards parents looking to help their children.

First, the FDA is clear in stating that there is NO CURE for autism which makes any treatment claiming to be a cure one thing - a lie.  

Next, they provide sound advice to help people have a more skeptical eye when considering one of these treatments. 

Their tips for determining treatments to avoid are: 

  • Be suspicious of products that claim to treat a wide range of diseases.
  • Personal testimonials are no...

In late January, the U.S. Food and Drug Administration (FDA) advised parents to stop using and immediately discard certain homeopathic teething products for infants because they contain belladonna, a toxic chemical in amounts that cannot be verified as safe. Now due to FDA findings of inconsistent and sometimes excessive levels of the poison in such products, a newly published alert indicates Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets are being voluntarily recalled by their manufacturer Standard Homeopathic Company. 

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