How Drugs are Developed and Approved by the FDA: Current Process and Future Directions

  title={How Drugs are Developed and Approved by the FDA: Current Process and Future Directions},
  author={Arthur A. Ciociola and Lawrence B. Cohen and Prasad M. Kulkarni},
  journal={The American Journal of Gastroenterology},
OBJECTIVES:This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near future.METHODS:A literature search was performed using MEDLINE to summarize the current FDA drug approval processes and future directions. MEDLINE was further utilized to search for all cost analysis studies performed to evaluate the pharmaceutical… Expand
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