An Overview of the Drug Research and Development Process (Regulatory Insights)

Those of us who have been writing regulatory documents for several years are often asked, "How can I break into regulatory writing from my background in (fill in the blank) basic science academics, nursing, medicine, technical writing, medical communications, etc?" Getting started is not easy, but it's not impossible either. Medical writing as a profession did not exist when AMWA began about 70 years ago. The writing then was done by physicians or other members of the research teams. Most people became medical writers by being in the right place at the right time and climbing the career ladder with a lot of hard work and on-the-job training. Today, medical writing has evolved into a recognized career choice with a growing number of opportunities for formal training at the university level. If you're not ready to enroll in an academic program, you can gain a basic understanding of the concepts involved in regulatory writing in other ways. A good place to begin any training is to learn about the drug development process and the regulations and guidelines that direct the research and provide the basis for the associated documents. This article is a starting point from which medical writers can (and should) continue to research and learn on their own in order to transition into the realm of regulatory writing for the pharmaceutical industry. This article describes the process for pharmaceutical (drug) products, but regulatory writers also work in other regulated areas, such as biologics, blood products, and medical devices. The regulations vary according to the agency that will review a given type of product, so be sure to research accordingly.