June 3, 2014 – The House Energy and Commerce Committee is seeking public comments from patients, providers and other stakeholders about how they learn about new treatments for their diseases or conditions, a discussion that is likely to fuel the debate over whether and how companies can disclose information about off-label uses for their products. […]
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new drugFDA Looks to Consumers for Pre-approval Input
May 23, 2012 – At an FDA meeting held last week to explore more effective ways of including patient input in regulatory decisions regarding drug, device and biological products, the agency made it plain to patients, caregivers, patient advocates and patient advocacy groups that it wants patient perspectives to be included in the process. “This […]
Read moreFormer FDA Policy Chief Says Consumer Group Request Would Slow Drug Approvals
June 16, 2011 – The Food and Drug Administration (FDA) should not mandate comparative effectiveness trials as part of the drug approval process, according to Scott Gottleib, a resident fellow with the American Enterprise Institute for Public Policy Research (AEI). Gottleib, a former FDA policy head, writes in AEI’s June issue of Health Policy Outlook […]
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