What do you know about FDA Approval?

Are you familiar with the fundamentals of FDA?

What is FDA?

The Food and Drug Administration (FDA) is the US government agency. It approves all drugs for marketing before they are made available to the public. The agency enforces laws on the manufacturing, testing and use of drugs and medical devices.

What are FDA regulations?

FDA regulations are set of regulations framed by FDA. These are intended to protect the rights, safety, and welfare of participants involved in studies subject to FDA jurisdiction.

What is an FDA Approval Letter?

An approval letter means that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approval letter. Drug products cannot be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that imposed by FDA. A firm has to be notified in writing that its application has been approved.

Find out the A – Z index of FDA approved drugs at FDA