Volume 22, Issue 1 - Medical Writing Education

Regulatory Writing

Author: Gregory Morley

Abstract

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References

1. Goldacre B. Bad pharma, how drug companies mislead doctors and harm patients. London: Fourth Estate; 2012.
2. EMA/CHMP/376406/2011. Questions and answers on the potential off-label use of celecoxib in patients with familial adenomatous polyposis. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2011/05/WC500106538.pdf
3. EMA/272931/2011. Policy on the determination of the condition(s) for a Paediatric Investigation Plan/Waiver (scope of the PIP/waiver) Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/09/WC500133065.pdf
4. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2012;344:d7373.