| To help safeguard American consumers, the Food | | | | as its pharmacokinetics, or how the human body |
| and Drug Administration or FDA plays a significant | | | | absorbs and distributes the drug to the system. The |
| role in pharmaceutical product development. The | | | | second phase of human clinical trials is concerned with |
| FDA, through its Center for Drug Evaluation and | | | | the effectiveness of the drug, and can involve |
| Research, conducts extensive testing to ensure that | | | | hundreds of volunteer patients. Once a drug has |
| these drugs are both safe for human use and | | | | passed the first two phases, it undergoes a much |
| effective for the diseases or conditions they are | | | | larger scale of testing, which can last up to several |
| intended to treat. | | | | years. |
| Initially, potential new drugs are tested in laboratories. | | | | Once the FDA is satisfied that the drug is beneficial |
| Once enough pre-clinical data has been acquired for | | | | and that the manufacturer is able to produce the |
| companies to consider moving on to patient trials, the | | | | product at high levels of quality, the drug can be |
| company submits an Investigational New Drug (IND) | | | | approved for sale in the USA. However even after it |
| filing to the FDA. After an IND is approved, several | | | | has been approved, the pharmaceutical product |
| phases of clinical human trials are conducted, during | | | | development process can still continue. The FDA may |
| which the FDA tests for both safety and | | | | require another phase of post-approval surveillance in |
| effectiveness. | | | | order to watch for side effects that may not appear |
| The first phase of clinical human trials assesses the | | | | initially. |
| safety of a new drug in healthy volunteers, as well | | | | |