How the FDA Drugs Development & Approval Process Works

  FDA

The FDA controls the drug-approval process and is tasked with reviewing new drugs and medical devices. FDA’s best-known job is to evaluate new drugs before they can be sold. CDER’s evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Phases of FDA Drug-Approval

What does it mean by FDA approved drugs?

FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

FDA Drug Patents

Federal law allows generic-drug companies to work on drugs to gain FDA approval before the patents held by the brand-name companies expire. However, when a generic-drug maker files an application with the FDA, it must notify the patent holder if it’s challenging the patent that exists, meaning if the company is claiming the drug doesn’t infringe on the patent or the patent isn’t valid.

Difference Between Traditional Approval and Accelerated Approval  

Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available.

How long does it take to get FDA Approval ?

The FDA approval process can be long, tenuous, and frustrating, especially for patients waiting on new or generic drugs to hit the market. Although the intention of the process is to ensure patient safety and drug effectiveness, there are some elements that may prove unnecessary and can be expedited under critical circumstances. The FDA has developed four methods to speed up the approval process for drugs designated as such.

  • Fast Track: this process is designed to speed up development and expedite the review of drugs that treat serious conditions and “fill an unmet medical need”.
  • Breakthrough Therapy: this process expedites drugs that are found to be substantially more effective for a certain condition than others on the market.
  • Accelerated Approval: this process is for drugs that fill an unmet medical need and have evidence of potential clinical benefit (although they don’t yet prove clinical benefit).
  • Priority Review: this designation means the FDA has a goal of making a decision on a drug application within six months.
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How the FDA Drugs Development & Approval Process Works
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How the FDA Drugs Development & Approval Process Works
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The FDA controls the drug-approval process and is tasked with reviewing new drugs and medical devices. FDA's best-known job is to evaluate new drugs before they can be sold. CDER's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
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Plianced Inc.
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