In July, the FDA approved the Repatha Pushtronex System. This is a single-dose delivery system that allows patients to receive 420 mg of the PCSK9 inhibitor in a single dose using SmartDose technology. The device should be available to consumers sometime in August. [click to continue…]
In 2007, the FDA was tasked with developing a system for identifying and analyzing the risks associated with medical devices after they entered the market. The Sentinel Initiative was launched in 2008 in an effort to track the necessary information in a federal database. In February, the most advanced form of the Sentinel Initiative became fully operational, yet there are some concerns that the tracking and monitoring capabilities of the current system do not go far enough.
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Vaping has become more popular since it’s been on the market. However, the more prominent it is in the marketplace, the more it can be watched and regulated. Manufacturers of vaping products have begun filing lawsuits against the FDA for what they allege is an overstepping of the authority granted them in the Tobacco Control Act of 2009. On August 8, the first portions of the final rule, delivered in May, will go into effect. [click to continue…]
In July, the FDA approved a new treatment, named Xiidra as a treatment for dry eye disease. Dry eye disease is a condition where a person does not produce enough lubrication to keep the eye healthy. Xiidra is the first treatment to be approved in a new drug classification designated lymphocyte function-associated antigen 1 antagonist. [click to continue…]
Summer is when hurricane awareness comes to the forefront of the collective consciousness. The Atlantic hurricane season officially begins on June 1 and lasts until November 30. Now is a good time for individuals to review their first aid kit and make sure they have all necessary medical supplies easily accessible or included in their hurricane preparations. [click to continue…]
The FDA recently released a press announcement to communicate the dangers of using loperamide in ways other than instructed. Loperamide is drug intended to be used to control diarrhea. The most common brand name is Imodium, but there are several generic options available. It is available without a prescription and widely accessible. [click to continue…]