A recent focus of the FDA has moved toward combination products and how to best regulate those products. A combination product is any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product as defined in 21 CFR [...]
Posted on 16. Nov, 2015 by Karl Kapp.
As technology advances, the FDA is moving to enforce the claims and statements made by mobile app developers. The FDA regulates: Mobile apps that transform a mobile platform into a regulated medical device and therefore are mobile medical apps Mobile apps that connect to an existing device type for purposes of controlling its operation, function, [...]
Posted on 09. Nov, 2015 by Karl Kapp.
In August 2015, the FDA issued non-binding recommendations and guidance related to their thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. The proper name of a biological product reflects certain scientific characteristics of the product, such as [...]
Posted on 05. Nov, 2015 by Rob Sims.
I was fortunate enough to once again attend the annual RAPS conference, held in Baltimore, MD on October 26 and 27. One of the more interesting sessions was focused on the pending changes to MEDEV 2.7.1 Rev. 4 guidelines, which are related to clinical evidence requirements for medical devices. Because UL EduNeering has more than [...]
Posted on 02. Nov, 2015 by Karl Kapp.
A fascinating report has been recently issued which discusses the future of science and policy at the FDA but, first, a little background. According to the report’s authors, in 2013, the Commissioner of Food and Drugs charged the Food and Drug Administration’s (FDA’s) Science Board, an advisory committee of national experts across various scientific disciplines, [...]
According to a Wall Street Journal Article, President Barack Obama’s nominee to lead the U.S. Food and Drug Administration has received more than $200,000 in consulting fees from pharmaceutical companies during the 2009 to early 2015 time frame. The fees were then donated to nonprofit groups, according to a government spokesman. The nominee is cardiologist [...]
According to the FDA, “if you personally know 100 people living in the U.S., chances are that almost 10 will suffer from some form of a rare disease. If that makes it sound like rare diseases are not actually very rare in this country, that’s because there are 7,000 different rare diseases, 80% of which [...]
Posted on 14. Oct, 2015 by Rob Sims.
Here are just a few takeaways from sessions I attended at the MedTech Conference, held last week in San Diego: FDA Office of Regulatory Affairs Update: For the past few years, ORA has been moving to a specialization of investigators model, and 2016 will be a transition year for ORA. Expect more educational webinars and [...]
Posted on 12. Oct, 2015 by Karl Kapp.
Recently, a 62-year-old drug called Daraprim used to fight a life-threatening parasitic infection went from $13.50 a pill to $750. This is approximately a 5000% increase. One of the justifications for such a dramatic rise was that the company’s CEO indicated the increase was to help to fund the development of a better version of [...]