Regulatory Focus™ > News Articles > FDA Plans Meeting to Explore Ways to Involve Patient Advocacy Groups in Regulatory Decision-making

FDA Plans Meeting to Explore Ways to Involve Patient Advocacy Groups in Regulatory Decision-making

Posted 19 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration is announcing its intent to hold a meeting on how best to involve patients, patient advocacy groups and health professional groups in regulatory decision-making.

The meeting, FDA's first Patient Network program Annual Meeting entitled "Input into FDA Benefit-Risk decision-making: Opportunities and Challenges," is being hosted by FDA's Office of Special Health Issues and will be held on 18 May 2012.

FDA said in a statement, "the meeting will serve as a forum for FDA's patient stakeholders and the general public, including health professionals, academia, and industry to learn about the regulatory process related to the medical product life cycle, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to collecting and incorporating meaningful input that well represents broad patient perspectives into regulatory decisions.

FDA said it hopes to enable its Patient Network program to educate and inform patient stakeholders about FDA and provide a venue for advocacy for patient stakeholders within FDA

The agency also hopes to establish a Patient Network website, which can serve to accomplish the above goals and send out regular communications to stakeholders.


Read more:

FDA - Food and Drug Administration Patient Network Annual Meeting; Input Into Food and Drug Administration Benefit-Risk Decisionmaking: Opportunities and Challenges; Hosted by the Food and Drug Administration Office of Special Health Issues; Notice of Meeting


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