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Regulatory agencies require pharmaceutical companies to submit an application before a company can market new medical devices or pharmaceutical products. Applications for marketing approval are highly technical documents that are aimed at a scientifically sophisticated audience. Every country has different requirements. These requirements are established by their own regulatory agencies. Biomedical writers are involved in many aspects of writing documents that are submitted to the regulatory agencies.

In the United States, many different types of documents are required for submission to the FDA. The types of documents depend on the product. A biomedical writer may be involved in generating any number of documents. Examples of these regulatory documents are the 2 separate documents that the FDA requires a pharmaceutical company submit to obtain approval to market a new prescription drug.

1. The first document to be submitted is called the Investigational New Drug Application (IND). The IND allows research on a drug to begin in humans. The document contains background information on the drug that may include: 1) chemical and structural information, 2) summaries of animal studies, and 3) any prior use in humans in other countries. This information must be scientifically accurate and must be written to persuade the FDA to allow research with the new drug to begin.

2. The New Drug Application (NDA) is submitted after all of the research in humans has been completed. The NDA contains a write-up of the results of studies conducted in humans. For an NDA to be accepted it must contain the results of 2 well-controlled (link to glossary) clinical trials. Biomedical writers translate the clinical trial results that include physiologic data, pharmacologic data, and statistical data into a persuasive document. The purpose of this document is to convince the FDA that the drug is both safe and effective.

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Last Modified May 27, 1999