A Review on Drug Approval Process in USFDA
Year: 2025
Type: article
Abstract: Developing a new drug requires a great amount of research work in chemistry, manufacturing, controls, preclinical science, and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness, and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible for enforcing the rules and regulations and issuing the guidelines to regulate the marketing of the drugs. This article focuses on the drug approval process in the USFDA.
Author: Gilbert Tony K., Pavithra R., Arasu T., Mahendiran K., Bharathi M.*, Kannabirran V., Rajalingam D., Gnanasekar N.
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7077140912
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