Development & Approval Process | Drugs | FDA
Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.
FDA Drug Approval Process - Drugs.com
Aug 19, 2024 · What is the FDA approval process? The 4 phases of a drug approval process includes: The U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) …
Understanding the FDA Approval Process and PDUFA Dates
Mar 20, 2025 · The FDA reviews NDAs and BLAs to approve medications for sale and marketing in the US with decisions required by the PDUFA date. Since 2015, the FDA has approved an average of 47 …
FDA Approval Process for Drugs and Medical Devices - Healthline
Sep 19, 2025 · This article reviews the primary development and approval phases that a drug or medical device must undergo before being approved by the FDA.
The Drug Development and Approval Process - FDAReview.org
Review of the NDA typically lasts one to two years, bringing total drug development and approval (that is, the IND and NDA stages) to approximately nine years. During the NDA stage, the FDA consults …
Understanding the US FDA Drug Approval Process - Pharmaguideline
Dec 8, 2025 · In this post, we will understand the FDA approval process step by step from preclinical testing to post market surveillance and help you navigate this complex regulatory process with clarity.
What does FDA approval mean? A guide to understand the process
Sep 22, 2025 · FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people …
Pharmaceutical Drugs: Approval Timelines and the FDA
May 23, 2025 · What Is The Standard FDA Approval Process? Typically, the FDA’s drug approval process spans 12 to 15 years and involves several critical phases: Preclinical Research: Laboratory …
Drugs@FDA: Inside the Drug Approval Process and Safety
Aug 1, 2025 · After successful preclinical testing, an Investigational New Drug (IND) application is submitted to the FDA to begin human trials. The FDA reviews this application, which includes …
The FDA's Drug Review Process: Ensuring Drugs Are Safe and …
The drugs that do must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug--from the design of clinical trials to the severity of side effects to the ...