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Congress
FDA Reliance on Draft Guidance for Significant Policy Changes under…
In May, Senator Lamar Alexander (R-TN), the ranking member of the Senate HELP Committee, along with Senators Richard…
“21st Century Cures” Initiative Seeks To Accelerate the Pace of Cures and…
The 21st Century Cures initiative is a new bipartisan effort to bridge the gap between medical advances and the regulatory…
FDA: House Republicans Question Generic Drug Rulemaking Process
A large group of House Republicans is once against raising questions about the U.S. Food and Drug Administration's (FDA)…
Continuing Medical Education Legislative Activity
Within the last few months, legislators from across the country have introduced bills that involve Continuing Medical Education…
Senator Grassley Announces Plans to Create Whistleblower Caucus
Senator Chuck Grassley (R-Iowa) plans to create a "Senate Whistleblower Protection Caucus." Grassley's plan coincides with the…
SGR Temporary Fix to March 2015 Likely to Sail Through Congress, Includes…
In early March, we wrote that a bipartisan group of congressional lawmakers announced they had reached a deal on legislation to…
FDA Commissioner Addresses FDASIA, DQSA, and Opioid Abuse
FDA Commissioner Margaret Hamburg testified at the Senate Health, Education, Labor and Pensions (HELP) Committee, addressing…
CMS Ditches Proposed Changes to Medicare Part D
Last week we wrote about the unpopular proposed changes to Medicare Part D. Among the most problematic proposals was one to…
SGR Fix The Final Deal?
On Thursday, February 6th, a bipartisan group of congressional lawmakers announced they had reached a deal on legislation to…
Truth in Settlements Act: Seeks to Expose Exaggerated Settlement Penalties
Gigantic settlement figures, such as the $2.6 billion fine leveled on J.P. Morgan last week, may not be all they appear. Senators…