FDA drug candidacy acceptance criteria and steps: problems and way forward

Abstract

This chapter presents information on the Food and Drug Administration (FDA) acceptance criteria and steps, quality control, and safety assessment protocols. The approval of a drug by FDA generally entails that the data on the drug's effects have been reviewed by appropriate body such as the Center for Drug Evaluation and Research (CDER), which certifies that the drug provides benefits that outweighs its potential risks or not. The drug approval process takes place within a structured framework that includes analysis of the target condition and available treatments, assessment of benefits and risks from clinical data, and evaluating strategies for managing these risks. Because of the unique nature of botanical drugs, CDER developed plans and specific recommendations for botanical drugs to be submitted in new drug applications (NDAs). However, FDA has faced criticism that its processes are too long and too expensive. In this chapter we will discuss criteria and steps for acceptanceffigure of new drugs especially those of botanical origin and the problems facing this process which may include FDA postmarketing drug withdrawals because of safety issue that most probably cannot be corrected.