Clinical trials and the FDA
How the FDA approves medications for the public
The Food and Drug Administration (FDA) is a U.S. government
agency responsible for approving drugs and medical treatments.
The official mission of the FDA is to:
Protect public health by assuring the safety,
efficacy, and security of human and veterinary drugs,
biological products, medical devices, our nation’s
food supply, cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public
health by helping to speed innovations that make
medicines and foods more effective, safer, and more
affordable; and helping the public get the accurate,
science-based information they need to use medicines
and foods to improve their health.
In short, it is the job of the FDA to make sure that
drugs and medical treatments are safe and effective for
public use. If a pharmaceutical company wants to market
and distribute its drug, they need to conduct numerous
clinical trials. The FDA oversees every clinical trial
and has strict rules and guidelines in place to make
sure every clinical trial volunteer is treated as safely
and fairly as possible.
During clinical trials the pharmaceutical companies collect
data that will be sent to the FDA. After laboratory and
human trials are completed the FDA will examine the research
findings and determine if the drug meets the criteria
for their approval.
Each drug must pass through three phases of clinical
trials in order to obtain FDA approval.
Phase 1
Phase 1 clinical trials are conducted to determine how
the drug is absorbed, distributed in the body, metabolized
and excreted. Phase 1 clinical trials also measure the
duration of the drug’s effects.
Phase 2
Phase 2 clinical trials evaluate the drug’s safety. It is during this phase
that dosages and side effects are studied.
Phase 3
Phase 3 clinical trials test how effective the drug is at treating the condition
it is targeting. During this phase they also test side effects of long-term use.
After Phase 3, the pharmaceutical company then supplies the FDA with their findings
and can apply to for their FDA for approval. Once the FDA approves the drug,
the pharmaceutical company can begin marketing and distributing the new medication.
