The FDA and Pharmaceutical Product Development

To help safeguard American consumers, the Food and Drug Administration or FDA plays a significant role in pharmaceutical product development. The FDA, through its Center for Drug Evaluation and Research, conducts extensive testing to ensure that these drugs are both safe for human use and effective for the diseases or conditions they are intended to treat.

Initially, potential new drugs are tested in laboratories. Once enough pre-clinical data has been acquired for companies to consider moving on to patient trials, the company submits an Investigational New Drug (IND) filing to the FDA. After an IND is approved, several phases of clinical human trials are conducted, during which the FDA tests for both safety and effectiveness.

The first phase of clinical human trials assesses the safety of a new drug in healthy volunteers, as well as its pharmacokinetics, or how the human body absorbs and distributes the drug to the system. The second phase of human clinical trials is concerned with the effectiveness of the drug, and can involve hundreds of volunteer patients. Once a drug has passed the first two phases, it undergoes a much larger scale of testing, which can last up to several years.

Once the FDA is satisfied that the drug is beneficial and that the manufacturer is able to produce the product at high levels of quality, the drug can be approved for sale in the USA. However even after it has been approved, the pharmaceutical product development process can still continue. The FDA may require another phase of post-approval surveillance in order to watch for side effects that may not appear initially.