Online FDA Regulations: Implications for Medical Writers

Rita C. Tomlin San Diego State University

Abstract

Availability of online Food and Drug Administration (FDA) regulations is contributing to a shift in medical writers' organizational role from a peripheral to a central role where their responsibilities for the persuasiveness of documents and compliance with evolving regulations have increased dramatically. Therefore, curricula for medical writers should include instruction in persuasion, collaboration, strategic and project management, the drug development process, and the location and interpretation of FDA regulations.

Journal
Technical Communication Quarterly
Published
2008-06-06
DOI
10.1080/10572250802100410
CompPile
Search in CompPile ↗
Open Access
Closed
Topics
Export

Citation Context

Cited by in this index (6)

  1. Computers and Composition
  2. Journal of Technical Writing and Communication
  3. Journal of Technical Writing and Communication
  4. Communication Design Quarterly
  5. Journal of Technical Writing and Communication
Show all 6 →
  1. Technical Communication Quarterly

References (20) · 1 in this index

  1. Market Watch
  2. On rhetoric: A theory of civic discourse
  3. Technical Communication
  4. Technical Communication Quarterly
  5. Exploring the rhetoric of international professional communication: An agenda for teacher…
Show all 20 →
  1. Technical Communication
  2. Medical writing in drug development: A practical guide for pharmaceutical research
  3. New drug approval process: The global challenge
  4. New drug approval process: The global challenge
  5. 10.1177/009286159903300307
    Drug Information Journal  
  6. 10.1016/0167-6296(91)90001-4
    Journal of Health Economics  
  7. Rhetoric, innovation, technology: Case studies of technical communication in technology t…
  8. American Medical Writers Association Journal
  9. 10.1016/S0304-3959(02)00178-1
    Pain  
  10. The CenterWatch Monthly
  11. The structure of scientific revolutions
  12. New drug approval process: The global challenge
  13. 10.1377/hlthaff.21.5.33
    Health Affairs  
  14. 10.1177/009286159903300337
    Drug Information Journal  
  15. 10.1378/chest.130.3.921
    Chest