The Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) plays a large role in technology diffusion in the medical field, by:
- Ensuring the safety and effectiveness of drugs and medical devices
- Controlling access by deciding which drugs need prescriptions and which ones can be obtained over the counter
- Legislation requires the FDA to review the safety and effectiveness of a new drugs before being marketed
Watch the interview below with John Jenkins, Director of the Office of New Drugs at the Center for Drug Evaluation and Research. Pay particular attention to his comments on quality and safety of approved drugs, including post-approval surveillance.
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What the FDA Does
- Approve drugs for specific indications, although physicians may prescribe for other uses once drug is available (off-label use)
- The FDA also regulates foods, drugs, radiation-emitting devices, vaccines and biologics, animal and veterinary products, and cosmetics and tobacco.
- The USDA also regulates specific foods such as meat, poultry and eggs. Foodsafety.gov has comprehensive information on food safety, including recent product recalls.
The United States is the global leader in medical device innovation and the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is committed to assuring that American patients have timely access to important new technologies and next-generation products without compromising their safety. Each year, millions of American patients benefit from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives, and improve public health. CDRH is responsible for advancing public health and facilitating innovation to help bring novel technologies to market and make the medical devices that are already on the market safer and more effective.
What the FDA does NOT do:
- Fund studies
- Perform studies
- Require cost data
- Evaluate cost effectiveness
For more information visit the U.S. Food and Drug Administration website.
You can also explore the FDA Drug Approval Process Infographic provided as a Drug Approval Process (PDF). Alternatively, you can view it online.
