Personalized Medicine Versus The Public Health: FDA Debates The “Polypill”
This article was originally published in RPM Report
Executive Summary
FDA is beginning to solicit input from the medical community on review issues for a multi-ingredient cardiovascular product designed to control hypertension, platelet aggregation and cholesterol levels. The key issue is whether convenience and broad access make up for loss of individualized dosing. That is an important debate in the era of personalized medicine.
You may also be interested in...
Margaret Hamburg: The Public Health Commissioner
An interview with newly confirmed FDA Commissioner Margaret Hamburg.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
Medicare Reaffirms Faith In Formulary Review Process Ahead Of Part D Changes
Dramatic transformation in the US Medicare Part D benefit design does not require any changes to CMS’ overall approach to reviewing formulary submissions from private drug plan sponsors, the agency says in its final guidance implementing the design changes for 2025.