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== A Brief Overview of The FDA Approval Process for Drugs In 2022. == We're going to be learning the process that the FDA uses in the United States for the approval of drugs for marketing an investigational product. It has been very similar for a long time with some modifications obviously, forms do change periodically so visit the FDA website whenever you're going to be making an application to the FDA just to make sure that you're using the most current editions of the FDA forms. The safety and effectiveness of drugs are very essential for the treatment of every patient. So here are 5 things to know about how FDA approves a drug for use.

=== Discovery and Screening === The first step is the investigation and screening of proposed drugs. Initially, new drugs will be tested on animals before testing them on humans. Furthermore, in a few cases, new drugs are tested on multiple species to gather the facts/evidence about the safety of the compound under investigation. === Submission Of an Investigational New Drug Application === The drug sponsor submits an investigational new drug application (IND) to the FDA based on the initial testing results. The application is required to include the drug’s composition and the details of its manufacturing. The manufacturer also gives a roadmap to start testing the drug on humans in this application. The FDA evaluates the plan to determine the risk of clinical trials on humans, and whether these proposed trials will cause any illness or injury. === Clinical Trial in Humans === Usually, clinical trials in humans consist of three phases. Phase 1 emphasizes safety and typically includes 20-80 healthy volunteers. Phase 2 clinical trials with hundreds of people with some kind of disease or medical condition to check the effectiveness of the drug. Phase 3 typically includes thousands of patients and is used to gather more information about the safety and effectiveness in different populations and different doses. Application Reviews and Inspections After the clinical trials are complete the FDA looks carefully at all the animal and human testing data review the drug labeling information and inspects the facilities where the drugs will be manufactured to determine if the new drug is safe and effective. === Safety Monitoring === It is not possible to enlist all the possibilities of the drug’s effect in clinical trials, therefore, monitoring the safety problems of drugs become critical once the drug is available on the market to the general public. The role of the FDA’s post-marketing safety system is to detect adverse events and take regulatory action when needed.