What is New Drug

A new drug is a medication or therapy that has not been used before in clinical practice to treat a disease or condition. A new drug that is marketed in the U.S. must first obtain approval from the Food and Drug Administration.


A new drug may be an innovative new compound that is classified as a new molecular entity by the FDA, or it may be related to a previously approved product. Getting FDA approval for a drug is a multi-step process that takes years and millions of dollars.

How a New Drug Gets Approved

The process of getting a new drug to market involves the following steps –

  1. Development of a new drug compound
  2. Animal tests for toxicity, to ensure the compound is safe for humans
  3. Investigational New Drug (IND) application to the NDA
  4. Phase 1 clinical trials or studies, where the emphasis is on the drug’s safety and side effects
  5. Phase 2 clinical trials, where the focus is on the proposed drug’s effectiveness
  6. Phase 3 clinical trials, which are very large, multi-stage trials that gather more information about the drug’s safety and effectiveness
  7. New Drug Application (NDA) to the FDA, which is a comprehensive document containing all the above information
  8. NDA review by the FDA
  9. Drug labeling review and facility inspection by the FDA
  10. Drug approval (or rejection) by the FDA

The FDA’s Center for Drug Evaluation and Research, or CDER, is the specific body within the FDA that is involved with reviewing the new drug development process. The CDER has in-depth understanding of the science used to create new products, testing processes and manufacturing procedures, and the diseases and conditions that are sought to be treated by new products. The CDER provides the scientific and regulatory advice needed to bring new products to market.

A new drug candidate can fail at any step of the process, because the clinical trials are meant to establish unequivocally that the drug is safe and effective in treating the targeted indication. However, accelerated versions of the approval process can be employed in certain cases, such as the development of a promising new drug that may treat a rare or life-threatening condition.

The FDA has recently made efforts to increase its rate of drug approvals. The agency 47 new drugs in 2017, compared to 22 in 2016. FDA data shows that the agency has an average rate of 31 new drug approvals per year for the period between 2008 and 2017.