Authors:
Rambabu Inaganti

Addresses:
Department of Orthopedic Robotics R&D, Smith-Nephew, Pennsylvania, United States of America.

Abstract:

This intersection of drugs and medical devices in combination products is perhaps one of the most complex spaces under the regulatory landscape ruled by the U.S. FDA. One needs to be aware of classifying criteria, premarket pathways, and the obligations in postmarketing phases that are unique for combination products. The paper discusses the various challenges of FDA regulations, especially those in jurisdictions, and the requirements of clinical trials and manufacturing standards. Advanced tools such as Mathematica and Python have assisted in the smooth process of regulatory compliance by allowing complex data modeling, simulation of the outcome of clinical trials, and related manufacturing analysis to be compliant with FDA standards. The research study in good detail goes into existing frameworks with real-world case studies to show the nature of operational, legal, and scientific hurdles that stakeholders were facing; findings would suggest an integrated regulatory approach with better interagency coordination towards filling up gaps and improving compliance. It is hoped that this work will provide insightful guidance to companies and policymakers interested in applying Mathematica and Python tools for streamlined approvals while ensuring that safety and efficacy are maintained.

Keywords: FDA Regulations; Combination Products; Drugs and Devices; Regulatory Challenges; Premarket Approval; Advancing Health Technologies; Life Cycle Management; Regulatory Challenges.

Received on: 12/04/2024, Revised on: 30/06/2024, Accepted on: 09/08/2024, Published on: 01/09/2024

DOI: 10.69888/FTSHSL.2024.000252

FMDB Transactions on Sustainable Health Science Letters, 2024 Vol. 2 No. 3, Pages: 164-174

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