Archive for the ‘Combination Products’ Category

Combination Products: Can Partnerships Between Drug and Device Companies Streamline Efficiencies?

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 »

Obtaining a Combination Products Jurisdictional Designation

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 Growth Outlook for the Global Combination Products Market

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 »

Stay Ahead of Regulatory Inspections with Gap Analysis

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 »

Redefining What a New Drug Really Is

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 »

FDA Issues New Guidance on cGMP for Combination Products – A Quick Review

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 »