Volume 23, Issue 2 - Regulatory Writing Basics
A guide to pre-approval regulatory documents
Author: Raquel Billiones
Abstract
The following table provides a list of the most common pre-approval regulatory documents for drugs with their associated guidelines and regulations. The clinical study report (p86), clinical study protocol (p93), investigator's brochure (p96), and common technical document (and components; p101) are dealt with in detail elsewhere in this issue.
Download the full article
Visit the EMWA website
Search
Articles
Member Login
Links
Editoral Board
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Deputy Managing Editor
Alicia Waltman
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Alison McIntosh / Stephen Gilliver
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Jennifer Bell / Louisa Marcombes
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk