how does the fda approve drugs?
In: 2
First, a company brings pre-clinical and molecular data to the FDA that demonstrates that their potential drug could theoretically be safe and effective. They do this by testing the drug in test tubes (*in vitro*), in animals, and occasionally via computer simulations.
The company then submits an Investigational New Drug application, or IND. After reviewing the IND, the FDA gives permission for the company to start investigating the drug in humans. The company then conducts clinicals trials to test for 1) whether the drug works, and 2) whether the drug is safe. In most cases, there are 3 phases of drug testing.
Once the company has gathered the clinical data, they submit a New Drug Application, or NDA, to the FDA for review. NDAs contain a ton of information, from preclinical and clinical data, to manufacturing information, to molecule stability testing, even the packaging of the drug. The FDA reviews this information (typically over the course of a year) and makes a decision about whether or not to approve the drug.
Source: formerly worked in new drug approval at the FDA.
Company makes a drug->test it on cells in a dish-> tests it on animals. All of that is preclinical.
Clinical testing starts after the preclinical part is approved:
Phase 1- testing the drugs in humans to see how safe it is and to find the best dose. This is in healthy people and sometimes people in the later stages of diseases. Whether the drug actually works or not will be addressed in later phases
Phase 2- testing if the drug works in humans, plus checking side effects and safety.
Phase 3- testing if the drug works in humans, but in a larger sample. If a drug finishes phase 3, it can get officially approved for sale/use. Keep in mind this whole process from preclinical to completion of clinical (usually) takes many years
Phase 4- this is after the drug is approved and on the market. This is just looking for adverse events and checking that all is going well.
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