August 13th, 2011 by David Kroll, Ph.D. in Health Policy, Opinion
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A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.
The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.
Stepping back, the goal of the FSMA makes perfect sense: Read more »
*This blog post was originally published at Science-Based Medicine*
August 10th, 2011 by ChristopherChangMD in Research
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Glue ear is the layman’s term for thick mucoid effusion of the middle ear, usually due to chronic ear infections.
The fluid itself is like maple syrup and usually treated with ear tube placement followed by suctioning as much of the fluid out as possible. However, given there is always some residual present, antibiotic ear drops with steroids is often prescribed.
Unfortunately, these patients are at higher risk of requiring repeated sets of tubes after the body spits them out.
Why? Read more »
*This blog post was originally published at Fauquier ENT Blog*
August 6th, 2011 by BarbaraFicarraRN in Expert Interviews, Opinion
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This is the third part of a three part post addressing the legal concerns of social networking in the health care arena.
In part one, legal expert David Harlow, Esq., Health Care Attorney and Consultant at The Harlow Group, LLC in Boston, answered questions regarding “The Legal Implications for Doctors, Nurses and Hospitals Engaging in Social Media?”
In part two, Mr. Harlow answered questions related to the Pharma industry; “Legal Concerns: What Steps can Pharma Take to Engage in Social Media?”
The third part addresses a question from a follower on Facebook about the use of disclaimers.
Q: Barbara: A Healthin30 reader on Facebook writes: “I’m looking for a good disclaimer to put on a couple of medical practices’ Facebook pages. The AMA social media guidelines aren’t helpful. Do you have a good boilerplate you recommend? Thanks in advance for your help!” David, can you offer a couple suggestions?
A: David: Read more »
*This blog post was originally published at Health in 30*
August 3rd, 2011 by Berci in Announcements, News
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FDA has published an announcement about regulations regarding medical mobile applications.
The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:
a. are used as an accessory to medical device already regulated by the FDA
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or
b. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
(For example, Read more »
*This blog post was originally published at ScienceRoll*
July 29th, 2011 by MuinKhouryMDPhD in Opinion, Research
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Adverse drug events are a serious public health problem. Consider the following facts:
- an estimated 82% of American adults take at least one medication and 29% take five or more;
- 700,000 emergency department visits and 120,000 hospitalizations are due to adverse drug events annually;
- $3.5 billion is spent on extra medical costs of adverse drug events annually;
- at least 40% of costs associated with adverse drug events occurring outside hospitals can be prevented.
How can genomics help? Pharmacogenomics is the study of genetic variation as a factor in drug response, affecting both safety and effectiveness. The intended applications of pharmacogenomics research include identifying responders and non-responders to medications, avoiding adverse events, optimizing drug dose and avoiding unnecessary healthcare costs. The Food and Drug Administration has added pharmacogenomic information to the labeling for more than 70 drugs. Labels may include information on genetic determinants of clinical response or risk for adverse events.
In spite of current enthusiasm about pharmacogenomics in the research community, Read more »
*This blog post was originally published at Genomics and Health Impact Blog*
