What is the process regarding investigational new drug application from FDA?

No medicine can be marketed (both foreign and domestic) in The United States without the prior authorization of the FDA (Food and Drug Administration). Said authorization is granted when the drug meets the requirements of quality, safety and efficacy. It is also a subject to constant supervision of developments in terms of risks and new uses, so that this permit can be revised at any time. However, for a new drug to be tested on the American soil (on clinical phase), the Company also needs to apply for an investigational new drug application to the FDA.

FDA approval of new drugs

In the United States, all prescription drugs go through a comprehensive review and approval process by the Food and Drug Administration (FDA) before they can be prescribed. From the time a drug is initially tested until it is approved by the FDA, it can take between 8 and 10 years, except for some urgent life-saving drugs, for example: covid-19 vaccine.

Initial testing

Once the potential drug is discovered, the first step is to submit it to laboratory studies to see how it interacts with living cells and whether the drug could be toxic to cells.

Testing in animals

If the results of the tests in the laboratory are satisfactory, the drug can be tested in animals to find out what side effects it may have and to provide information on its effectiveness in treating the disease it is supposed to treat. That is, the next step is to check the safety and efficacy of the drug.

Investigational New Drug (IND) application

If results continue to be encouraging, investigators should submit an IND application to the FDA that summarizes information from laboratory testing and research (animal testing). The application must also include a proposal to begin conducting clinical trials in people.

Clinical Trials

If the FDA team approves the IND application, clinical trials with human participants can begin.

New Drug Application (NDA)

Once clinical trials have been completed, the next step is to submit an application for approval of the new drug for commercialization in the United States. The FDA reviews applications for very important drugs within 6 months, but typically takes about 10 months to review. If the FDA decides to approve the drug, its official technical data sheet is drawn up, describing the disease that the drug can treat, as well as its known side effects and warnings related to the product. After this comes post-marketing monitoring