Combination products, made up of two or more components, have skyrocketed in the healthcare industry in recent years; however, complying with evolving legislation can be a nightmare for manufacturers. Read more »
Combination products are defined by the U.S. Food and Drug Administration as products that are some combination of drugs, biological products and/or devices. For instance, a medical device packaged with the drug it administers would be a combination product. Read more »
The last three decades have seen vast growth in the development of therapeutic and diagnostic products that are a combination of two or more components. These products, termed combination products, are a distinct category of medical products regulated in light of their constituent parts. Read more »
The drug-device combination market is booming. On track to generate more than $115 billion by 2019, the industry is expected to overtake the growth of both the medical device and pharmaceutical sectors. Strategic partnerships between drug and device companies are a by-product of this sudden growth, and this one-size-fits-all model can significantly reduce costs, improve productivity and streamline processes. Here are three reasons why. Read more »
Combination products, by their very nature, are harder for the FDA to regulate than singular products. The former can be any type of manufactured goods that falls under the specific FDA guidelines and includes some combination of drugs, biologics, and medical devices. Since the FDA has created a more streamlined way to regulate these products, attempting to obtain a jurisdictional designation for combination products is the first step manufacturers should take toward meeting this regulation. Read more »
The global combination products market is growing and will continue to do so over the next five years. A study conducted earlier this year has forecasted that this market is likely to grow at a compound annual growth rate (CAGR) of 7.9% between 2013 and 2019. While this is fantastic news in many ways for your combination device manufacturing company, there are still important factors to consider such as the reasons behind the growth, the rise in competition it could cause, and the trends that are likely to follow. Read more »
Regulatory inspections from the FDA are often nerve-wracking for a manufacturing company and its employees. An inspection can come along at any time, which is why you must be fully prepared for the possibility in order to perform well. The FDA wants to know that there are systems in place that allow your company to show exactly what is going into its manufacturing processes and that you are working to make things better if they are not yet perfect. Read more »
New legislation was introduced in January of 2015 which seeks to change the way a new drug will be defined and, eventually, the amount of manufacturers interested in creating combination drugs. As a combination manufacturer, you will need to know how this specific legislation will affect you and how new combination drugs will be defined as well as how other companies may receive incentives to start manufacturing these products. Read more »
In January 2015 the FDA issued a new draft guidance document regarding the final rule on current good manufacturing practice requirements (cGMP) for combination products that was issued on January 22, 2013 and made effective on July 22, 2013. The guidance describes and explains the final rule, so it is important for all combination product manufacturers to understand the most influential topics that were covered. Read more »