Literature Reviews: The FDA Drug Approval Process

Journals frequently publish review articles; these articles serve as an extended summary of the disciplinary knowledge about a topic. While they are not research articles, i.e., descriptions of new knowledge in the field, they address specialized audiences with interests in a specialized subject. Such articles might seem easy to write, but they impose several tasks on authors. First, the writer has to understand the subject. For example, I might be a respected researcher in the role of serotonin update, but I would be unlikely to produce a publishable review article on NSAIDs. Expertise matters, and readers often select a review article on the basis of the author's expertise. Second, the writer has to create an integrated understanding of the topic. Simplistic, stitched-together sources aren't enough. You might think of the metaphor of pack ice in the Arctic: if you photographed the patchwork of pieces and claimed to understand the dynamics of the field, you'd be ignoring the fact that all these pieces float atop seawater. A good review article recognizes the undercurrent of intellectual development, problematic issues, and likely research trends that are important to the field. Thus, the phrase “literature review” is something of a misnomer because it scants the importance of creating a critical framework for the literature.

This assignment asks you to write a literature review of sources that critique the Food and Drug Administration's drug approval processes. Note that “critique” does not mean, “to complain about,” or “to find what's wrong.” To critique something is to evaluate its assumptions, assertions, integrity, etc. You will find articles that examine the FDA's process.

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This assignment requires the following preparatory work:

1. The creation of an annotated bibliography. You will use the instructions under Readings to write and post three (3) sources to the list serve. This information becomes available for use by anyone in class. This reduces pressure on individuals while simultaneously producing a richer set of sources.
   
   
2. Posting sample paragraphs from your paper as directed in class. These samples will exemplify good writing and thus serve as models. We will pay close attention to:
   • integrative paragraphs
     
     
   • transitional paragraphs
     
     
   • conclusions-with-boost

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The paper itself requires the following:

1. An understanding of literature review as a genre.
   
   
2. A clear understanding of the FDA's drug approval process.
   
   
3. The identification of important articles that critique the FDA process.
   
   
4. A clear understanding that your paper will review the literature about the FDA process.
   
   
5. The creation of a 7-10 page, documented paper the reviews the literature that discusses FDA drug approval processes.

1. Peer Review: discourse
2. FDA Approval Processes
3. The Limits of Discourse
4. Patient Education

1. Writing Resources
   
   
2. Content Tools
   

1. Instructor Email hugh@culik.com
   
   
2. Peer Assistance [list serve]