5.8.1: Approving Drugs, Vaccines, and Devices
The process used to develop pharmaceutical drugs, medical devices, and vaccines go through rigorous testing steps overseen by the U.S. Food and Drug Administration (FDA). The first phases are the preclinical phases in a laboratory setting, where the drug is developed, then tested on animals to determine absorption, metabolism, and toxicity of the drug. If it is approved for human trials, there are several stages:
- Stage 1: 20-100 subjects with the disease or condition. This stage is crucial to further establish the safety and dosage of the drug.
- Stage 2: Several hundred subjects with the disease or condition. This stage is used to determine the efficacy of the drug and any side effects.
- Stage 3: 300-3,000 subjects with the disease or condition. This stage is meant to further evaluate the efficacy and side effects in a larger population. Very few drugs actually make it to this stage.
- Stage 4: Several thousand subjects. This stage occurs after FDA approval, to continue to monitor the safety and efficacy of the drug (Office of the Commissioner, U.S. FDA n.d.).