Bill of Health

JULY 1, 2022

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-19 209

COVID-19 FDA Medicare Medicare 209

HIPAA Journal

JANUARY 23, 2024

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 83

Fraud FDA Medicaid Medicaid 83

Drug & Device Law

JANUARY 30, 2023

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

FDA Fraud Governance Medicare 72