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- From Ninth Graders to Health Care Elites: A Communications Lesson on the Power of Engagement
- What’s Next in Health Care Part II: Price Transparency – is it the Holy Grail?
- Accountable Health Care: The Silent Health Care Reform
- The FDA Likes Facebook? The AMARC Hysteria
- The Need for a Medical Surge
- Health Care: Now What
- The Real Hospital Quality Measures
- Happy Healthy Weight Week?
- Personalized Medicine – from Complexity to Clarity
- APCO Forum: What’s Next in Food
Monthly Archives: September 2011
The international community gathers for the United Nations High-Level Meeting (UN HLM) on Non Communicable Disease (NCDs) this week in New York. Many are optimistic that the UN HLM will intensify focus within the international community on NCDs and solidify the link between NCDs and economic growth. The UN HLM has the potential to be the beginning of a global drive against NCDs. But this global drive must positively engage all sectors of society for it to be successful. On September 14, 2011, The Washington Post and Eli Lilly and Company hosted a one-day event, “Sharing the Responsibility: Noncommunicable Diseases.” The event brought together leaders from the health care industry, government, academia and NGOs to discuss the challenges of managing NCDs in advance of the UN HLM. Panelists discussed best practices, the role of private-public partnerships and looked at next steps in the fight against NCDs.
Posted on Tuesday, September 20th, 2011 By Melissa Musiker
Last week, the FDA released its long-awaited recommendations for the upcoming Prescription Drug User Fee Act (PDUFA) reauthorization of 2012. PDUFA authorizes FDA to collect user fees from drug companies that file new drug applications. In return for the fees, sponsor companies are guaranteed that their applications will be reviewed in a timely manner. Under this framework, FDA funding for drug approvals is not disrupted by the annual budget and appropriations process—which has become a bit of a political circus, given current pressures to cut back on government spending and reduce the federal deficit. Industry and beltway insiders have been buzzing that the package will likely pass through Congress without serious disruption. FDA has been in negotiations with key stakeholders such as PhRMA, BIO, and other stakeholders for over a year to sort out the technical details of the package. As proposed, the recommendations do not drastically change the drug approval process the way PDUFA did following the last reauthorization under FDAAA. A few key changes in the package include:
Posted on Thursday, September 8th, 2011 By Polly Webster