DRUG - DEVICE COMBINATION PRODUCTS: COMPARATIVE REGULATORY PATHWAYS IN THE UNITED STATES AND INDIA

A new dynamic in medical product development and regulatory approval was brought about by drug-device combo products. and business interactions that offer insightful insights for the creation of new combo product generations. With their promise for novel treatments, combination products which combine pharmaceuticals, biologics, and medical equipment have completely changed the healthcare industry. Every healthcare product in the pharmaceutical sector is divided into three categories: drugs, devices, and biologics. Each of these categories is governed by a different regulatory authority department. This article explores the complex world of safety, efficacy, and regulatory issues related to combination products.