The Affordable Care Act (ACA) is one of those programs people either love or love to hate. Regardless of what side of the fence one comes down on, it has undeniably changed the landscape of healthcare since its inception in 2010. One of the recently documented benefits of the ACA is that more people are receiving treatment in the form of increased prescription drug use while paying less for it. This is especially true for people with chronic health conditions. [click to continue…]
A biosimilar is a biological medical product that is manufactured by a different company but almost identical to an original product. These are officially approved versions that are generally produced after the patent expires on the original product. These products are typically molecularly complex and manufacturing differences can be problematic. Because of the increased potential for different effects between a biosimilar and the original biologic compound, there are specific regulations which let doctors and pharmacists know in greater detail how comparable two biological products are. [click to continue…]
September is National Recovery Month. Our Families, Our Stories, Our Recovery is the theme for 2016. The theme was chosen in order to focus on the valuable contribution families make to the recovery process. The Substance Abuse and Mental Health Services Administration provides many free resources for individuals and groups that wish to promote awareness of patients who are recovering from a mental disorder or a substance abuse disorder. There are several classifications of mental disorders, yet anxiety disorders and mood disorders are two of the most well-known. Substance abuse disorders can involve any type of substance that is habitually abused. [click to continue…]
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…]