Write about the approval process of Combination Products, either in the United S

Question

Write about the approval process of Combination Products, either in the United States or overseas.

In addition to the subsequent global marketing of the new combination product, your bosses would like to know the detailed steps in which this would be accomplished.

For example, which Forms (FDA & overseas), classification, product verification/validations, and FDA/overseas meetings, etc would be helpful. Also, any associated costs that include testing such as lab bench, animal, and clinical testing, if required.

Your bosses would appreciate if they knew exactly what are the many steps and milestones involved and the estimated costs (don't worry if information regarding cost is not available). This applies to both overseas and the United States. Don't worry if you are not able to have the exact cost since this is a complicated process. Try to get the information already available on the internet (US FDA has most of this information on their site already).

present the best case scenario to your bosses, who have to present to the stakeholders.

Write about the approval process of Combination Products, either in the United States or overseas.

In addition to the subsequent global marketing of the new combination product, your bosses would like to know the detailed steps in which this would be accomplished.

For example, which Forms (FDA & overseas), classification, product verification/validations, and FDA/overseas meetings, etc would be helpful. Also, any associated costs that include testing such as lab bench, animal, and clinical testing, if required.

Your bosses would appreciate if they knew exactly what are the many steps and milestones involved and the estimated costs (don't worry if information regarding cost is not available). This applies to both overseas and the United States. Don't worry if you are not able to have the exact cost since this is a complicated process. Try to get the information already available on the internet (US FDA has most of this information on their site already).

present the best case scenario to your bosses, who have to present to the stakeholders.

Explanation / Answer

A combination product is product composed of any drugs and device, biological product and a device . Depending upon the type of combination product, it's approval, clearence, licensure may be obtained through submission of single marketing application or through separate marketing application for the individual Constituent parts of combination product. For most combination product a single marketing application is sufficient for the product's approval, clearence . In some cases sponsor have to submit teo marketing applications for a combination of product when one application would suffice.

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