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 [...]
Saline solutions used during hospital admissions is running low. In an effort to keep up with demand, some suppliers are taking unprecedented shortcuts. The Food and Drug Administration is warning hospitals and healthcare providers that some suppliers are distributing "training solutions" instead. What is that you say? Training, or "practice", solutions are non-sterile products intended [...]
Over the summer, the Texas State Board of Dental Examiners approved the rule which allows dentists to independently diagnose, treat and monitor any dental condition related to benign snoring or obstructive sleep apnea. Dentists interested in taking advantage of this must complete 12 hours of education in sleep-disordered breathing the first year of treating patients [...]
Just a day after the Food and Drug Administration announced that a black box would be required for power morcellators, a large hospital chain bans the procedure. HCA Holdings, Inc., the largest for-profit U.S. hospital operator, has implemented a prohibition on the use of power morcellation in laparoscopic uterine surgeries in its facilities. The impact [...]
FDA will require manufacturers of power morcellators to place "boxed" warnings on their devices. Earlier this year, FDA recommended against the widespread use of the procedure. The new warnings will better inform women that using power morcellators to remove uterine growths may contribute to spreading cancer inside their bodies and decrease the odds of long-term survival. Power [...]
So you, or someone you know, has a great idea for how to market a medical device. You start telling folks about your idea and make it part of your marketing efforts. Do you stop to think "how would I survive on Shark Tank" or "how would I survive in prison"? Well, you, or someone [...]
