Conclusion

CPs will bring therapeutic solutions to many unmet medical needs. However, undertaking the development of a CP requires a thorough understanding of the development and regulatory issues, as well as skilled project planning. Determining the primary mode of action and subsequently obtaining designation and classification of the drug-device CP is one of the first steps in the development program, because this dictates the requirements for premarket approval. CPs that consist of unapproved entities present additional scientific and regulatory hurdles. These issues must be defined early on and addressed in the development plan. Project teamwork is even more critical with this type of product, because the team will have to address issues related to both drugs and devices. Despite these challenges, CPs that consist of unapproved components can be brought successfully to the clinic and subsequently commercialized.

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