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

@article{Ciociola2014HowDA,
  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},
  year={2014},
  volume={109},
  pages={620-623}
}
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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5
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References

SHOWING 1-10 OF 17 REFERENCES
The cost of biopharmaceutical R&D: is biotech different?
The costs of developing the types of new drugs that have been pursued by traditional pharmaceutical firms have been estimated in a number of studies. However, similar analyses have not been publishedExpand
The cost of drug development: a systematic review.
TLDR
Despite three decades of research, no published estimate of the cost of developing a drug can be considered a gold standard and studies on this topic should be subjected to reasonable audit and disclosure of the drugs which authors purport to provide development cost estimates for. Expand
Medical device recalls and the FDA approval process.
TLDR
Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review, suggesting that reform of the regulatory process is needed to ensure the safety of medical devices. Expand
Spending on New Drug Development
This paper replicates DiMasi et al (2003, 2004) estimates of expenditure on new drug development using publicly available data. The paper estimates that average expenditure on drugs in human clinicalExpand
The gold industry standard for risk and cost of drug and vaccine development revisited.
Gold dimensions of pharmaceutical drug development indicate that it takes on average 11.9 years, with an investment around US$ 0.8 Billion, to launch one product on the market. Furthermore,Expand
The price of innovation: new estimates of drug development costs.
The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drugExpand
Estimating the cost of new drug development: is it really 802 million dollars?
TLDR
This paper replicates the drug development cost estimates of Joseph DiMasi and colleagues, using their published cost estimates along with information on success rates and durations from a publicly available data set, to estimate the cost per new drug between 1989 and 2002. Expand
Drug development costs when financial risk is measured using the Fama-French three-factor model.
TLDR
Using the Fama-French three factor model, the cost of drug development is found to be higher than the earlier estimate, and the authors' base case estimate was $802 million. Expand
β ℕ Revisited
We have obtained two results since leaving Chapter 3 which make this return to βℕ possible. The first of these was Corollary 4.30 in which we found, under the assumption of the Continuum Hypothesis,Expand
Department of Health and Human Services Food and Drug Administration, Prescription Drug User Fee Rates for Fiscal Year
  • Federal Register
  • 2012
...
1
2
...