Archive for the ‘Combination Products’ Category

Off-label uses… the Windex of the medical field?

You’ve heard the term, “cure-all”, I’m sure, but as we all know, there is no real “cure-all” in life. If you ever watched the movie, “My Big Fat Greek Wedding”, then you are all too familiar with the father of the bride who believes that Windex is the “cure-all” for everything. As he states in the movie, “from psoriasis to poison ivy, put some Windex on it!” Windex, however is not a magic potion. It is simply intended for cleaning windows, mirrors, glass shower doors, glass top stoves and more as stated on their website. In fact, Windex in high concentrations can be very caustic, because it contains ammonia! Maybe the father of the bride should have done some research before promoting Windex’s unapproved uses!

In the medical field, doctors, like the father of the bride in the movie, use many products for unapproved uses. In our industry, the Food and Drug Administration (FDA) requires that medical devices, drugs, biologics and combination products be used according to its labeling of approved (or “on- label”) uses. Oftentimes, however, doctors end up using products for “off-label” use. With this FDA requirement, how is it that doctors are able to use these products for unapproved uses? Read more »

How to Determine a Combination Product’s Primary Mode of Action

Combination products raise distinct regulatory challenges because they comprise two or more regulated components. Depending on its constituent parts, your combination product may require a review by several agency centers at the U.S. Food and Drug Administration (FDA). The FDA will then designate one agency center as the lead agency center for your combination product. This center will oversee the pre-market review and regulation of your combination product as a whole. Read more »

Will the FDA’s Intercenter Pilot Project Improve the Combination Product Submission Review Process?

Combination products present regulatory challenges because their constituent parts must be reviewed by more than one agency center. Under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act, combination products are assigned to a lead center based on their primary mode of action. The lead center then consults with other centers that oversee one or more of the product’s constituent parts. Recognizing the need for more timely and consistent consults, the FDA recently initiated Phase 1 of its new intercenter consult request (ICCR) process for combination products. Read more »

Can the FDA keep pace with the science behind drugs and medical devices?

Understanding the science behind drug, biological and medical devices ensures that combination products are safe for the market. The Food and Drug Administration (FDA) needs to collaborate with the Center for Drug Evaluation and Research, Center for Devices and Radiological Health and Center for Biologics Evaluation and Research — the three medical product centers — when determining the reliability of drugs and devices. Read more »

How to Determine the Right Regulatory Path for Combination Products

Recent FDA reforms — such as the federal agency’s lean management model and new Combination Products Policy Council — plan to simplify combination product review. However, getting a medical device to market is still a lengthy process — on average, it takes 12 years to get a product into a pharmacy — and complex.

Developing a regulatory strategy helps you align FDA regulatory requirements with your business model so you can overcome some of the challenges associated with combination product review. Read more »

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 »