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Regulatory Writing: Review process in regulatory writing

Authors: Gregory Morley

Recently, Phil Leventhal posed the question ‘What does it take to go from being a good medical writer to an excellent one?’ on EMWA's LinkedIn Discussion Group. My impression is that the responses were written largely with medical communications (that is, texts for publication) in mind rather than regulatory writing per se. Posters made plenty of useful suggestions such as a focus on the target audience and forward planning. Given the involved debate about ghost writing, I was perhaps a little surprised though that there was no mention of ensuring that the thoughts and opinions of (all) named authors are included. According to my understanding, medical writers are channels through which the intellectual authors can express themselves appropriately. This presumably involves interacting and negotiating with authors during review rounds to ensure that the text is representative of the desires of the headline authors.

Medical Writing. 2015;24(2):97–98

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