Technical communication and the development of a Request for Designation (RFD) submission to the U.S. Food and Drug Administration (FDA).

摘要

In this dissertation, I use autoethnography to retrospectively examine the development of a document submitted to the U.S. Food and Drug Administration (FDA). Specifically, I retrospectively examine my perceptions of the corporate history and corporate culture surrounding the development of the biotech product, how the history and culture influenced the company's development of a Request For Designation (RFD) FDA submission, and how the RFD affected subsequent events in the company.;RFDs are a relatively new type of FDA submission designed specifically for a newly added division within the FDA---the Office of Combination Products (OCP)---formed to evaluate combination products. Combination products are biotech products not easily classified as being solely a biologic, device, or drug. The OCP reviews a combination product's RFD to assess if a biotech product achieves its primary mode of action (PMOA) through physical (device), chemical (drug), or organic (biologic) means. The purpose of the RFD is to persuade the OCP reviewer to classify the product as per the sponsor's preferred recommendation---assuming the sponsor can build a sufficiently viable argument supporting the sponsor's recommended PMOA. The OCP's determination of PMOA directly affects the development time and expense involved in obtaining clearance from the FDA to market a new biotech product.;Although a maximum of only 15-pages in length, an RFD can determine the fate of a new biotech product or the company sponsoring the product. Considering the critical nature of an RFD, it seems natural that hiring a technical communicator to assist in the development of a persuasive-yet-factual RFD should be paramount to a biotech company. However, there is currently little or no discussion of the roles technical communicators play in the development of RFDs and other FDA submissions.;By documenting my experiences and observations, it is my intent to objectively share my discoveries and thoughts on developing an RFD (and tangentially other FDA submissions) with other technical communicators so as to provide insight into this new area of exploration within the discipline.