What is required for FDA approval?
To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.
What are the FDA requirements for bringing a drug to market?
A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.
What is one thing the FDA does for drugs?
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
How many employees does FDA have 2020?
Food and Drug Administration
| Agency overview | |
|---|---|
| Jurisdiction | Federal government of the United States |
| Headquarters | White Oak Campus 10903 New Hampshire Avenue Silver Spring, Maryland 20993 39°02′07″N 76°58′59″WCoordinates: 39°02′07″N 76°58′59″W |
| Employees | 14,824 (2010) |
| Annual budget | $3.16 billion (2020) |
Where does FDA get its funding?
The Food and Drug Administration has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated. Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug.
How big is the FDA staff?
More than half of the FDA’s staff is employed at CDER and the Office of Regulatory Affairs (ORA), according to employment statistics the FDA posted on its transparency site, FDA Basics. As of May 20, the agency consisted of 15,100 employees.
What agency does FDA fall under?
the Department of Health and Human Services