Medical Writing Regulatory Writing Basics In the Bookstores

Volume 23, Issue 2 - Regulatory Writing Basics

In the Bookstores


Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare by Peter Gøtzsche; Radcliffe Publishing, 2013. ISBN: 978-184619-884-7 (paperback). 24.99 GBP. 310 pages.

Mastering Scientific and Medical Writing: A Self-help Guide by Silvia M Rogers; Springer, 2014 (2nd edition). ISBN: 978-3-642-39445-4. 26.99 GBP. 116 pages.

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  1. Jacobs A. In the bookstores: Bad Pharma. Medical Writing 2013;22(1):50–1.
  2. World Health Organization. The top 10 causes of death [updated 2013 Jul; cited 2013 Dec 10]. Available from:
  3. Doctors are the third leading cause of death in the US, killing 225,000 people every year [2000 Jul 30; cited 2013 Dec 10]. Available from:
  4. Hall H. Death by medicine [2008 Jun 24; cited 2013 Dec 10]. Available from:
  5. Jacobs A. Are big pharma like the mafia? [2013 Dec 10; cited 2013 Dec 10]. Available from:
  6. Cancer Research UK. Long-term survival from once-deadly cancers doubles [2010 Jul 12; cited 2013 Dec 10]. Available from:
  7. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21(2):317–22.
  8. Ford ES, Ajani UA, Croft JB, Critchley JA, Labarthe DR, Kottke TE, et al. Explaining the decrease in U.S. deaths from coronary disease, 1980–2000. N Eng J Med 2007;356(23):2388–98.
  9. Pulling back the curtain on the organized crime ring that is the pharmaceutical drug cartel [2013 Oct 16; cited 2013 Dec 10]. Available from:
  10. Alliance for Natural Health. ANH-Intl exclusive: interview with Dr Peter Gotzsche, author of “Deadly Medicines and Organised Crime” [2013 Nov 27; cited 2013 Dec 10]. Available from:
  11. What Doctors Don't Tell You. Adverse reactions: light in the darkness [2013 Nov 29; cited 2013 Dec 10]. Available from:
  12. Ponsford D. What Doctors Don't Tell You – the magazine that freedom of speech campaigners want withdrawn from sale [2013 Oct 10; cited 2013 Dec 10]. Available from:
  13. Drees B. A call to abandon the useless anachronism of the ‘define at first use’ rule for abbreviations. Medical Writing 2013;22(4):316.



Regulatory writing basics
Message from the President
A guide to pre-approval regulatory documents
Effective authoring of clinical study reports: A companion guide
The clinical study protocol and medical writing: A good fit?
The Investigator's Brochure: A multidisciplinary document
An overview of the Common Technical Document (CTD) regulatory dossier
Good clinical practice (GCP): A universal call for ethics in biomedical research
Adverse event reporting: A brief overview of MedDRA
The approval process of medicines in Europe
Recommended procedures for retracting articles: Inadequate and patchily applied? Analysis of a recent article in PLoS One
The needs assessment in continuing medical education
Origin and development of English for Medical Purposes. Part II: Research on spoken medical English
Did minor flaws in a new drug reveal major flaws in company publication practices?
What every medical writer needs to know
Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy
In the Bookstores
Journal Watch: Dedicated medical writing rotation for pharmacists, publication of drug industry funded research, and evidence-based medicine for clinical decision making
Regulatory Writing: The essence of regulatory writing as defined by its jargon
Medical Communication
News from the EMA
English Grammar and Style: Points of view
The Webscout
Gained in Translation: Science at the multilingual crossroads
Out On Our Own
The Light Stuff


The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk