New Drug Application

A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration

The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.[1][2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.[1]

The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug.[3] Among facts needed for the application are:[2]

Exceptions to this process include voter driven initiatives for medical marijuana[4] in certain states.

  1. ^ a b "The Drug Development Process". U.S. Food and Drug Administration. January 4, 2018. Retrieved May 1, 2018.
  2. ^ a b "The Drug Development Process. Step 4: FDA Drug Review". U.S. Food and Drug Administration. January 4, 2018. Retrieved May 1, 2018.
  3. ^ Gad, Shayne Cox (2008). Pharmaceutical Manufacturing Handbook: Production and Processes. John Wiley & Sons. ISBN 9780470259801.
  4. ^ Commissioner, Office of the. "Public Health Focus - FDA and Marijuana". www.fda.gov. Archived from the original on April 28, 2018. Retrieved April 30, 2018.