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What are the 4 phases of drug approval?

Drug development can be divided into four phases: discovery, preclinical studies, clinical development and market approval. The image below provides an overview of the process, including an estimated timeline for each step. Lets go through the process step by step.

What are the 3 primary phases of FDA approval process?

There are three primary phases of the approval process: pre-clinical trials, clinical trials, and new drug application review.

Which center within the FDA is responsible for the drug approval process?

The main consumer watchdog in this system is FDAs Center for Drug Evaluation and Research (CDER). The centers best-known job is to evaluate new drugs before they can be sold.

What is the approval process of the FDA?

Drugs undergo laboratory and animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.

Which of the FDA approval phases occurs after FDA approval?

Phase IV clinical trials happen after the FDA has approved medication. This phase involves thousands of participants and can last for many years. Investigators use this phase to get more information about the medications long-term safety, effectiveness, and any other benefits.

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