Chapter 30 - Regulatory Approval and Compliances for Biotechnology Products

Abstract

This chapter provides an overview of the regulatory requirements and procedures for the evaluation and approval or clearance of biomedical products (drugs, biologics, devices, in vitro diagnostics and combinations thereof). National Regulatory Authorities (NRAs) such as the US Food and Drug Administration (FDA) regulate biomedical products to ensure that patients and consumers have access to high quality, safe and effective products, and restrict access to those products that are unsafe or have limited clinical use. Regulatory procedures impact all stages of biomedical product development. Therefore it is critical that developers of biomedical products possess the knowledge and awareness of the regulatory challenges and opportunities to expedite the development of safe and effective products in a cost-effective manner. The pathway from discovery to marketing of a new biomedical product can be long, complex, and costly. A clear understanding of the FDA regulatory process, regulations, and policies is essential when developing an effective product life cycle management strategy. The aim of this chapter is to provide an overview of the FDA regulatory product approval process and discuss considerations for successfully developing a regulatory strategy that leads to product-marketing authorization (or clearance for devices) and provides important principles for approval from other NRAs.