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Abstract

The trend of combining drugs and devices has brought about advancements in medical product development, regulatory approval, and business involvement. These combination products are designed with modern links between key technologies and complementary elements, while still maintaining their fundamental purpose. To better understand the benefits and drawbacks of these combination medications, we will look at case studies of drug-device stents and transdermal patches. It seems that this generation of combination products has created a new, high-value area, as evidenced by advancements in product control and the realization that the competitive advantage lies in the sophistication of the mix. Recent studies show that combining technology, medicine, and biologics creates a developing opportunity. According to our analysis, a new type of combination product's first product includes both the regulator and the sponsor. If this first product is granted a license, it can greatly reduce uncertainty around the entire class of combination medications, establishing a leading regulatory center. The sponsor of a new type of combination product is crucial in reducing uncertainty by helping decision-makers understand the fundamental objective of the combination product.

Keywords

Drug-device combination, combination product, Drug, Device, Biological products, FDA

Reference

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Yashashri K. Deore
Corresponding author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Sakshi V. Dashpute
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Vaibhav B. Gunjal
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Sejal R. Pagar
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Shivraj P. Jadhav
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

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Dhananjay M. Patil
Co-author

Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, Maharashtra

Yashashri K. Deore*, Sakshi V. Dashpute, Vaibhav B. Gunjal, Sejal R. Pagar, Shivraj P. Jadhav, Dhananjay M. Patil, A Comprehensive Review Of Drug-Device Combination, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 56-70. https://doi.org/10.5281/zenodo.10065508

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