Abstract
The EMA, the FDA, and Health Canada head to head
A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health Canada).
In a previous column, I talked about the importance of review cycles, and also about how inefficient they can be. In particular, the column talked about how some reviewers inappropriately focus on certain details while failing to address high-level failings. Another essential aspect of a successful review cycle is of course the resolution of comments.
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References
- Downing NS, Aminawung A, Shah ND, et al. Regulatory review of novel therapeutics – comparison of three regulatory agencies. N Engl J Med 2012 May 16. [Epub ahead of print] PMID: 22591257.
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- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Katharine Webb (INC Research, in Munich, Germany)
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Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Karin Eichele (Novartis Pharma, Nürnberg, Germany)
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- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
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- Simon Page (Cambridge Medical Communication Ltd, Cambridge, UK)
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- Satyen Shenoy (Describe Scientific Writing & Communications, Cologne, Germany)
- Claire Gudex (Klinisk Institut, Odense, Denmark)
- Evguenia Alechine (Epsilon Scientific Communication, Buenos Aires, Argentina)
- Beatrix Doerr
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