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.https://www.fda.gov/about-fda/what-we-do
According to FDA, there are two types of approval processes with different time frames.https://www.fda.gov/drugs/development-approval-process-drugs
- STANDARD DRUG REVIEW: This type of review is applied to a drug that offers little to no improvement over other therapies already on the market. The goal for standard review is to get a drug through the approval process in 10 months.
- PRIORITY DRUG REVIEW: Priority Review means that FDA aims to take action on an application within six months, compared to 10 months under standard review. A Priority Review designation directs attention and resources to evaluate drugs that would significantly improve the treatment, diagnosis, or prevention of serious conditions.