Archive for the ‘Combination Products’ Category

Will the FDA’s New Combination Products Policy Council Help with Key Decision-Making for Combination Products?

In March, the FDA spearheaded a lean management model that will transform the combination product review process. Now, the federal agency has introduced a new committee that will address industry policy issues, a change that could have a significant effect on manufacturers. The Combination Products Policy Council will centralize the classification and review process, which, the FDA claims, will “ensure alignment and consistency” across the board. But will the reforms really help with combination product decision-making? Read more »

Will FDA Changes Lead to a Better Combination Products Review System?

You need to decipher ever-complex guidelines and a labyrinth of legislation before you can get a combination product to market. Correct product labeling and training is no longer enough; your company requires comprehensive workflows to mitigate the risks involved in the manufacturing process. The FDA hopes to iron out the kinks in combination product review with a new lean management model, which was announced in March. But what does this mean if you already struggle with FDA-imposed rules and regulations? Read more »

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 »