I am following the results of this survey closely and will provide updates. Here, I focus on this question:
How is adverse event information from these sources being received, reviewed, and processed?The survey asks respondents to choose ONLY one of the following responses (and/or add additional comments):
- Special group within the company is responsible for receiving, reviewing, and processing AEs (Internal Group)
- Receiving and processing AEs is outsourced to a specialized agency; review is handled in-house to determine which AEs need to be reported as required by law (Outsourced)
- The information is usually incomplete and does not meet the requirements for submitting a meaningful AER (not actionable)
- We have no SOP (standard operating procedure) for receiving, reviewing, and processing AEs from these sources (No SOP).
- None of the above
- Don't Know
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents).
SPECIAL REPORT: FDA Regulation of Social Media
Find links to more results here.