Sentinel Research, Communication Transparency Needed, GSK’s Troy Urges
Executive Summary
FDA needs a more open, transparent process for developing plans for drug safety studies in its Sentinel electronic data surveillance project as well as for announcing results, GlaxoSmithKline Senior VP and General Counsel Daniel Troy urged during a conference on Sentinel Jan. 12.
You may also be interested in...
Equal Access To Data Needed For CER To Be Effective, NPC Exec Says
With the Patient-Centered Outcomes Research Institute beginning the early grant process and other data collection initiatives such as FDA’s Sentinel and Janus programs also underway, National Pharmaceutical Council Chief Science Officer Robert Dubois is recommending changes in policy that will allow equal access for industry and academia to data used in comparative effectiveness studies.
Equal Access To Data Needed For CER To Be Effective, NPC Exec Says
With the Patient-Centered Outcomes Research Institute beginning the early grant process and other data collection initiatives such as FDA’s Sentinel and Janus programs also underway, National Pharmaceutical Council Chief Science Officer Robert Dubois is recommending changes in policy that will allow equal access for industry and academia to data used in comparative effectiveness studies.
PDUFA V: Sentinel, Regulatory Science Upgrades Could Gain User Fee Funding
FDA’s Sentinel Initiative appears to be gaining support through the Prescription Drug User Fee Act, although industry is not interested in blindly pumping user fee revenue into the project.