Michael Werner

Michael Werner

Holland & Knight LLP

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Drug Quality and Security Act Gives FDA Authority to Regulate Drug Compounding and Creates Uniform Federal Standards for...

On Nov.18, Congress enacted sweeping changes to the laws governing the safety of the drug supply. The Drug Quality and Security Act (the act) clarifies FDA's authority to regulate drug compounding. It also creates uniform...more

11/19/2013 - Drug Distribution Drug Manufacturers FDA Prescription Drugs

Controversial U.S. Medical Study Raises Informed Consent Questions

The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with human subject protection regulations in medical research....more

5/10/2013 - Compliance Ethics Informed Consent Medical Research Safety Precautions

CMS Issues Final Physician Payment Sunshine Rule

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

2/5/2013 - CMS Compliance Continuing Medical Education Drug Manufacturers Enforcement Exclusions Medicaid Medical Devices Medical Research Medicare Payment Records Penalties Physicians Reporting Requirements Sunshine Act Vendors

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