FDA regulation of combination products is a very important aspect to keep in mind for pharmaceutical manufacturers. This is because of the complex nature of combination products. The definition for combination products is set out in 21 CFR 3.2 (e). Combination products assume importance in the industry because they combine two more drugs from different categories. This is what makes them unique. If a product is made out of two or more drugs from the same category, it does not qualify as a combination product.
Complex procedures which often involve specialized areas such as tissue engineering and biomedical nanotechnology go into combination products. This is why FDA regulation of combination products is very critical. FDA regulation of combination products is important also because these regulations are applied to areas that extend beyond just drugs. Combination products are manufactured in the areas of food, cosmetics and nutraceuticals.
Assigning a combination product to an Agency Center or another organizational component that has primary jurisdiction for its premarket review and regulation is set out under section 503(g) (1) of the FD and C Act. The criterion for this assignment is the determination of the “primary mode of action” (PMOA) of the combination product.
New field of combination diagnostics
FDA regulation of combination products has been gaining increased attention of late because of the emergence of the exciting and promising new field of combination diagnostics. In a nutshell, this area concerns the use of the combination of a drug with an in-vitro diagnostic (IVD). This area signals a big shift from existing methods because it helps a physician or any other medical professional to gauge the effectiveness of a drug before it is given to the patient. Prior to the rise of this field, the effectiveness of a drug could be ascertained only after the patient was given it.
All these facts promise a bright future for the area of combination products, but also highlight the role of FDA regulation of combination products. Any new, or for that matter, existing area of work or methodology or technology has to be regulated by the regulatory bodies around the world.
A webinar on the FDA regulation of combination products
An in-depth discussion of the FDA regulation of combination products will be made at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Thomas E. Colonna, who provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics and holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia, will be the speaker at this webinar. To gain a thorough understanding of FDA regulation of combination products, please visit http://www.compliance4all.com/control/w_product/~product_id=501096LIVE/~sel=LIVE/~Thomas_E.%20Colonna/~FDA_Regulation_of_Combination_Products to enroll.
In this session on FDA regulation of combination products, Thomas will cover the following important areas relating to the topic:
o Definition of combination product
o FDA Regulatory Pathways
o Primary Mode of Action
o User Fees