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Health Care Reform and Its Impact on FDA and Pharma
Last week, the excruciatingly long and unpredictable path of health care reform passed another milestone when President Obama held a summit at Blair House among leaders in Congress to try to forge out...
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New Drug Proposed for FDA Regulation of Cosmetics
Recently there have been a number of new laws proposed or enacted aimed at giving the FDA more authority over both food and drugs. However, another area (often overlooked) of regulatory authority is...
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Food Safety Modernization Act – Passed but Not Funded – A Conversation with...
Many were surprised when at the end of the 111th Congress, the Food Safety Modernization Act was passed and in early January, President Obama signed it into law. FDA Commissioner Margaret Hamburg was a...
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House Appropriations Proposes Specific Cuts for the Continuing Resolution
Yesterday morning I posted about impending budget cuts to FDA for the next fiscal year and posed the question whether or not less money might equate to less enforcement. Ironically, a short time later,...
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FDA Funding – When the Audience Changes, the Message Must Change
On March 11, Dr. Margaret Hamburg presented testimony before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies regarding funding for the FDA....
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Bills, Bills, Bills – An Update on Legislative Proposals
It has been a while since providing an update on legislative proposals introduced in Congress that would impact the FDA, medical products and food industries. With Congress out on recess, it seemed...
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Let the Sunshine Part 1 – The Case of the Missing Guidelines
It may have escaped the notice of some that The Physician Payment Sunshine Act – legislation proposed that would bring greater transparency to the relationship between medical product manufacturers and...
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Let the Sunshine – Part 2 – Why is it Important?
As noted yesterday, the Physician Payment Sunshine Act is now law, but so far, the deadline for Health and Human Services to provide guidance to medical product manufacturers on what exactly to report...
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Now What? Post-Election and FDA
We are finally post-election. The sense of relief that one can watch or listen to broadcast television or radio without seeing campaign ads is still being felt nationwide. Facebook sidebars are free...
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Election Impact – The New Class
Around elections, I have usually tried to provide some insight into where candidates stood on health care related issues, particularly affecting the development and marketing of medical products. I...
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Is There a Doctor in the House? The Medical Background of Congress
Congress oversees a great deal that has to do with health care. You may have heard a little about that little piece of legislation that was passed called the Affordable Care Act (a/k/a Obamacare),...
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Legislative Proposals in the 114th Congress
Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed. The new Congress has just two months old...
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This is Your State – This is Your State on Drugs
In years gone by, I have taken occasion to write a posting with this title to take a look at the policy activity that is going on at the state level that impacts medicines. It has been a few years...
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This is Your State, This is Your State on Drugs
I always enjoy doing a periodic check in on what states are doing when it comes to healthcare issues. Utilizing the excellent data base resources at the National Conference of State Legislatures, one...
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Local Ballot Initiatives Impacting Health and Healthcare
There is a good deal of commentary about what happened at the nationally in this year’s election cycle. But a good deal happened at the state level as well – things that will impact healthcare and may...
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New Directions for FDA, Part 1 – 21st Century Cures
One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the...
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New Directions for FDA, Part 2 – Regulatory Matters
In Part 1 about change facing FDA, we looked at the 21st Century Cures Act and some of the change that would be in store for FDA. But in this post-election cycle, there is more than pending...
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Healthcare Reform – Where Are We? – An Invitation
Over the past three decades, we have gone from Hillarycare to Obamacare to Trumpcare. The mere fact that healthcare is characterized by the names of public figures is testament to the extreme...
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