Question

Outline the process that has to happen before a new medication can be released safely to the public.

Answer 1

1.Discovery and Development :

Research for a new drug begins in the laboratory.

2. Pre-clinical Research :

Drugs undergo laboratory and animal testing to answer basic questions about safety.

3.Clinical Research :

Drugs are tested on people to make sure they are safe and effective.

 4.FDA Review :

FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.

 5.FDA Post-Market Safety Monitoring :

FDA monitors all drug and device safety once products are available for use by the public.