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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Frequency, Characteristics, And Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs. Fixing The FDA’s Orange Book. Coverage of New Drugs in Medicare Part D. J Am Pharm Assoc (2003). A full posting of abstracts/summaries of these articles may be found on our? Health Aff (Millwood). 2022 May 3.

COVID-19 208
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HHS-OIG Excludes Theranos Founder and CEO from Federal Health Programs for 90 Years

HIPAA Journal

The Theranos Scandal Theranos was a blood testing startup founded by Elizabeth Holmes in 2003. The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. The company was investigated by the Federal Bureau of Investigation and shut down.

Fraud 82
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Building a Quality Education Program That’s Good Enough 

YouCompli

If you are in clinical research, this means looking at the FDA requirements, ICH-GCP Guidelines, and other applicable regulations. Working at a behavioral health hospital, you will need to review state regulations, Joint Commission standards, and Medicare requirements. John is the Director of Quality at Sunrise Vista in Canton, Ohio.

Nurses 52
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Logical Contradiction Doctrine:  Buckman for Textualists

Drug & Device Law

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72