Online FDA Regulations: Implications for Medical Writers

摘要

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.