US FDA’s Regulatory Considerations and Framework for Approval of Controlled Release Delivery Systems

The prime intent of the current book chapter is to provide a holistic overview of United States Food and Drug Administration (USFDA’s) regulatory approval process for controlled release delivery systems while highlighting the critical aspects taken into the consideration. Administering the medication(s) at a well-controlled rate ensures the highest possible level of efficacy and safety. Consequently, drug delivery systems with regulated release patterns are being developed to optimize bio-pharmaceutics, pharmacokinetics, and pharmacodynamics properties of drugs. Thus, such systems being recognized as newer class of drugs follow different regulations for their approval into the market. Hence, it becomes quite appealing to know the aspects being considered for framing the regulations and pathways being followed for such approvals. In this chapter, we have provided a brief account on the controlled release delivery systems and their mechanisms of drug release followed by bird’s eye view of USFDA regulatory considerations and framework for their approval. The multitude of benefits offered by controlled delivery systems makes it essential to have stringent regulations for their approval. In this regard, there are rules in place, with different pathways available, by regulatory agencies, such as FDA for controlled release formulations. The safety and effectiveness of the pharmaceuticals rely heavily on the rigor of pharmaceutical regulations around the world. They control not only drug prices but also standards. Thus, the primary objective of the review is to conduct a thorough examination and furnish a discerning appraisal of the regulatory framework governing controlled release delivery systems, as presently embraced by the USFDA.