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# PDUFA Sub-Group Discusses Safety Communication
- URL: https://www.fdaweb.com/pdufa-sub-group-discusses-safety-communication/
- Published: 2016-01-27T12:00:00.000Z
- Updated: 2026-09-15T02:31:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134575

> The PDUFA 6 reauthorization post-market subgroup discussed three safety communication issues at its 11/18/15 meeting to determine whether they should be part of negotiations related to PDUFA-funded drug safety activities. Meeting [minutes](http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM481712.pdf?ref=fdaweb.com) identify the three issues as tracked safety issues, 921 postings, and Sentinel analyses.  
>  
> Agency officials reviewed the current process for notifying sponsors about new tracked safety issues and heard industry representatives raise concerns about inconsistent implementation of the policy. The agency said there is a process improvement effort underway, including a review of the process for communicating with sponsors.  
>  
> FDA and industry representatives discussed the possibility of including the quarterly posting of Section 921 safety issues in ongoing reauthorization negotiations and agreed that it would be important to consider any underlying FDA resource needs. The agency is to explore this further for discussion at a future meeting.  
>  
> Finally, FDA explained that its goal is to be transparent about using the Sentinel System and public posting of information is one way to do that. As with concerns about the other two safety communication issues, the industry representatives discussed the importance of receiving advance notice of communications so that companies are prepared to address inquiries from patients, healthcare professionals, and other members of the public. This issue also is to be explored further at a future meeting.