Developing A Framework for Life Cycle Management of Combinational Products

Authors

  • Madhumathi Sai Durga.K, Raghava.D, Nageswara Rao.K, Naga Sravani.P Author

DOI:

https://doi.org/10.48047/

Keywords:

Combination products, life cycle management, regulatory framework, drug device, FDA, EMA, CDSCO, post-market surveillance, regulatory compliance

Abstract

Combination products—comprising drug-device, drug-biologic, or device-biologic elements—present unique regulatory and management challenges throughout their life cycle. As global regulatory bodies such as the US FDA

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Published

2025-10-07

Issue

Vol. 16 No. 10 (2025): Volume 16 Issue 10 (2025)

Section

Articles