FDA approves Compliance Issues with drug & device combination products


Drug / device combination products increased compliance and regulation in the pharmaceutical industry. On their own, each drug and device has its own special brand of marketing and good manufacturing practice regulations. However, when drugs and devices are mixed, they pose new compliance question – how will this new composite products be managed as a whole? Pharmaceutical consultants point out that there is not one easy solution

Combination products consist of the following :. Products that are combined with two or more regulated drugs, devices or biologics (eg drugs / devices, biological / drug or drugs / device / biologic). Because of the diversity of these drug / device combinations, a one-size-fits-all approach does not always work. For example, these drugs / device products can be either a pharmaceutical package with devices or drugs coated on the device. Another combination is drugs and devices that are packed separately. This separate drugs and devices can be produced by different manufacturers.

Another issue that arises is complex drugs / device combinations. Combined products could be as simple as a syringe filled with drugs. They could be as complex as chemotherapy drugs combined with monoclonal antibodies.

The US Federal Drug Administration (FDA) has made it a priority to address these ongoing compliance issues. They developed Combined Office Products (OCP) as the result of Medical Devices participation fee and Modernization Act of 2002 (MDUFMA). The OCP has taken the mystery out of the compliance process for drugs / device combinations, and has proved successful.

main priority The OCP is to ensure that these combined products are sent to the appropriate FDA Centers. They oversee timely premarket reviews of combination products. The OCP is also consistent, effective regulations on the market.

However, OCP not handle the whole process with drugs / device combination product followed. They decide first “primary mode of action.” The drug / device product The OCP identifies what is “important therapeutic action of a combination.” Based on this “primary mode of action,” the OCP manages these drugs / devices goods following Centers based on their analysis. The responsibility lies on the following FDA centers :. Center for Biologics Evaluation and Research (CBER), Center for Drug evaluation and Research (CDER) and the Center for Devices and diagnostic Health (CDRH)

Because the rules tangled with combination products, the FDA created an effective way to deal with this problem. The OCP wrote SOP for IntercenterConsultative / Partnership Review Process. It outlines the necessary procedures and processes to three Centers must follow when passing combination products.

The FDA also consult with candidates and helps them with marketing programs. According to the FDA, one marketing applications for combination products usually work for clearance. Depending on the combination product, the FDA can recommend two separate applications marketing. The FDA advises applicants to contact the OCP to discuss relevant marketing programs based on drug / device combination thereof.

Pharmaceutical consulting agreed that OCP FDA has made great strides in recent years have been an issue for drugs / device products. The OCP conducts training for both staff and applicants throughout the year to resolve product issues together.

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