Regulatory writing

Gregory Morley

Volume 21, Issue 3 - Writing Matters

Regulatory writing

Author: Gregory Morley

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.

Greg Morley

Freelance and Contract Medical Writer, Spain

greg.morley@docuservicio.com

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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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Volume 21, Issue 3 - Writing Matters

Regulatory writing

Author: Gregory Morley

Abstract

Download Full Article

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