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

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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.

According to reliable resources mentioned above it takes:

180 days, 0 hours, 0 mins, 0 secs