Recently, the FDA) issued warning letters to dietary supplement companies whose products contained an ingredient which is not approved for such use under federal law. The warning letters were issued to: 1ViZN LLC, Lehi, UT; Beta Labs, Newark, DE; Blackstone Labs LLC, Boca Raton, FL; Brand New Energy LLC, Burbank, CA; Core Nutritionals LLC, Arlington, VA; DSEO LLC, Riverside, CA; Genomyx [...]
Have you checked the wrists of the people you are around? Chances are that they, and perhaps you, are wearing data gather devices aimed at tracking steps, heart rate and calories burned. For those fitness conscious, or looking to improve their health, these new fashion accessories are a means of confirming all of the activity [...]
The Texas Medical Board recently updated its telemedicine rules. Patients may now "visit" their doctors with a "face-to-face" visit held either in person or via telemedicine. Essentially the only scenario prohibited in Texas is one in which a physician treats an unknown patient using telemedicine, without any objective diagnostic data, and no ability to follow-up with the [...]
A lawsuit filed in Missouri seeks class-action status for fail to safeguard sensitive data held by health insurer Anthem Inc. A lawsuit first filed on behalf of a Richmond, Missouri, woman has been amended to add three plaintiffs who allege personal data stolen during the breach in December or January is responsible for fraudulent tax returns [...]
Medical students, residents and fellows spend hours perfecting their ability to decipher symptoms that impact a patient's health. Words memorized from various textbooks are turned into actions as scientific principles cross paths with real-world applications. Seldom, however, are these highly motivated practitioners exposed to the business side of practicing medicine after their academic training is [...]
To manufacture and market prescription drugs, a manufacturer's laboratory and manufacturing facility should ensure certain sterility for the products produced. Good manufacturing practices as well as good laboratory practices help maintain the integrity of prescription drugs. Recently, the federal government unsealed a 37-count indictment charging Med Prep Consulting Inc. for sterility issues. Med Prep has [...]
I enjoyed speaking to the Houston Area Residential Care Homes meeting this week. The monthly meetings focus on providing education and networking opportunities to owners of assisted living, personal care and home health agencies. Barbara Hoover, who has a wealth of regulatory and administrative experience, serves as one of the chapter's officers. The discussion centered [...]
Pharmaceutical companies spend millions of dollars and thousands of hours on research and development to produce a prescription drug that meets FDA's approval. For a new drug, the approval process is known as a New Drug Application (NDA). These new drugs, also known as pioneer drugs, enjoy a period of market exclusivity for the manufacturer's efforts. [...]
As many as 80 million customers of health insurance company Anthem Inc., have had their account information stolen. Hackers accessed information such as names, birthdays, medical IDs, Social Security numbers, street addresses, e-mail addresses and employment information. There is a black market for such information which places consumers at risk for identity theft. The Affordable Care [...]
Many US consumers believe that their diet is inadequate to provide them with all of their nutritional needs. Others believe that there are natural solutions to common physical ailments. Consumers have turned to dietary supplements as a means of supporting their health and lifestyles. Retailers, large and small, in store and on-line, are profiting from [...]
