Regulatory Writing Basics

The Food and Drug Administration (FDA) regulates the pharmaceutical industry in the United States. The FDA has five centers, which are responsible for prescription and over-the-counter drugs, medical and radiological devices, food and cosmetics, biological products, and veterinary drugs.

The FDA’s Center for Drug Evaluation and Research (CDER) evaluates the safety and efficacy of new drugs before they go on the market. But CDER does not conduct testing of drugs—that is the responsibility of the pharmaceutical company which develops the product. The company tests the drug in animals and humans and then submits documents with evidence of its safety and effectiveness. Scientists at the FDA then review the documents submitted.

As a regulatory writer, possible documents you would write include clinical study reports, investigator brochures (manuals on conducting a clinical trial), and regulatory submissions (INDs, NDAs, CTDs, MAAs). Click here to read more about these documents.

As a regulatory writer you should have good knowledge of clinical study design and conduct; how to write protocols and how to read and interpret clinical data (summary tables and listings). You should also be aware of case report form design, good clinical practice (GCP) regulations and regulatory document guidelines such as the ICH.

Are you interested in regulatory writing? In a couple of weeks I will release an affordable and comprehensive online course called "Introduction to Regulatory Writing in the United States." So stay tuned.