The race for drug approvals: hasten slowly?
- PMID: 29789869
- DOI: 10.1007/s00228-018-2490-9
The race for drug approvals: hasten slowly?
Keywords: Accelerated approval; EMA; FDA; Harm-benefit; Market withdrawal; SMC; Surrogate.
Comment in
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Response to the letter to the Editor regarding Zeukeng et al.'s article A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.Eur J Clin Pharmacol. 2018 Sep;74(9):1199-1200. doi: 10.1007/s00228-018-2486-5. Epub 2018 May 26. Eur J Clin Pharmacol. 2018. PMID: 29802425 No abstract available.
Comment on
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A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.Eur J Clin Pharmacol. 2018 Jun;74(6):811-818. doi: 10.1007/s00228-018-2431-7. Epub 2018 Feb 22. Eur J Clin Pharmacol. 2018. PMID: 29470610
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