The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter. When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the drug proves to be effective and safe, the FDA will approve it. However, the FDA requires some drugs to be furthered studied and require additional clinical trials. When the drug is officially approved, the FDA sends an approval letter to the company- this process may take many years. Some important steps taken for an approval are (2008 Internet Drug News Inc.): Synthesis & Purification - FDA estimates that it takes approximately eight-and-a-half years to study and test a new drug before it can be approved for the general public. This estimate includes early laboratory and animal testing, as well as later clinical trials using human subjects.
Animal Testing (short term) - Generally, two or more species (one rodent, one non-rodent) are tested because a drug may affect one species differently from another.
Animal Testing (long term) - Long-term testing in animals ranges in duration from a few weeks to several years. Some animal testing continues after human tests begin.
Institutional Review Boards - Ensures the rights and welfare of people participating in clinical trials. Confirms participants are fully informed and have given