for FDA to approve new drug

❤️ If you've found this 'How long does it take' article helpful, share it with others ❤️
Reading Time: < 1 minute

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.[1]
According to FDA, there are two types of approval processes with different time frames.[2]

  1. 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.
  2. 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.

How long does it take for FDA to approve new drug?

According to reliable resources mentioned above it takes:

180 days, 0 hours, 0 mins, 0 secs

References for this How long does it take? article

References for this How long does it take? article