Aspects of Regulation Concerning the New Drug Approval Procedure in the USA

Abstract

Pharmaceutical technologists, pharmacologists, and medicinal chemists all contribute significantly to science during the drug-development process. The drug approval process involves several steps, including discovery, pre-clinical testing, clinical testing, investigative new drug application filing, and new drug application filing. Before authorized drugs are put on the market in the USA, the US FDA is the regulatory body that assesses their efficacy and safety. Drug reviewers work for regulatory bodies all over the world, and it is their job to determine whether the study results support a new drug product's quality control, safety, and efficacy in serving public health. This article describes how innovative pharmaceuticals are discovered, marketed, and launched into the market while taking safety concerns FDA reviews new medications and devices promptly and does a respectable job of attempting to safeguard the public. However, scientific considerations are only one part of the regulatory equation due to incentives for speed, conflicts of interest in decision-making, restricted legislative mandates, low funds, and limited surveillance once products access the market. These restrictions may result in patients being unnecessarily exposed to medicines whose hazards outweigh their benefits, deceptive advertising of new medications, and the promotion of less effective over more successful treatments.