Senate Judiciary Subcommittee Holds Hearing on CREATES Act
Recently, the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights held a hearing to examine Senate…
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Senators Send FDA Letter with Concerns Over Draft Guidance Documents
Four United States senators sent a letter to United States Food and Drug Administration (FDA) Commissioner Robert Califf…
Interstate Medical Licensure Compact – Expands to 17 States
Seventeen states have enacted legislation in an attempt to expand access to health care through expedited medical licensure. The…
FDA Holds Public Meeting on Monograph Fees
The United States Food and Drug Administration (FDA) has announced that it will start to gather information on creating…
Is the Carrot Bigger Than the Stick? – The DOJ’s FCPA “Pilot…
Kurt Stitcher, Senior Compliance Consultant
The U.S. Department of Justice's FCPA Pilot Program is nominally designed to…
JAMA Internal Medicine Bias – Now You See Me
Merlin the Magician would be proud of a recent study published in JAMA Internal Medicine attempting to prove that…
CMS: Hospital and Critical Access Hospital (CAH) Changes to Promote…
CMS recently released a proposed rule updating the Conditions of Participation (CoP) for 6,228 hospitals and critical access…
How the FDA Is Doing with Medical Devices and the Medical Device Industry
The FDA and the GAO both released data on the FDA's performance in medical device regulation over the last several years. This…
Carl Reichel Warner Chilcott Executive Acquittal Deals Blow to Yates Memo
In a blow to the Department of Justice and the Yates Memo, a Massachusetts jury acquitted Warner Chilcott executive Carl Reichel.…