DOJ Settlement with Sentynl Therapeutics Over Hiring Physician’s Girlfriend…
Recently, the United States Department of Justice (DOJ) announced a $750,000 settlement with Sentynl Therapeutics, Inc., of Solana…
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McKinsey Reaches $78 Million Settlement with Health Insurers and Payers
McKinsey and Company recently agreed to a $78 million settlement over its role in the opioid epidemic, advising opioid…
CMS Finalizes Prior Authorization Rule
Federally regulated health insurers will have to turn around prior authorization decisions much more quickly under a recent rule…
FDA Issues Guidance Documents on Direct-to-Consumer Advertisements
To increase transparency and consumer awareness, the Food and Drug Administration (FDA) issued a final rule to amend its…
FDA Authorizes Florida Preliminary Clearance to Import Drugs from Canada
For the first time, the Food and Drug Administration has authorized a state to import prescription drugs from Canada, granting…
FDA Issues Guidance Documents to Streamline Premarket Review and Approval…
The United States Food and Drug Administration (FDA) recently issued two guidances as part of its Drug Competition Action Plan…
CMS Releases Additional Information about the Cell and Gene Therapy (CGT)…
The Centers for Medicare and Medicaid Innovation (CMMI) previously released three new payment models, all aimed at lowering drug…
John Crowley Steps up as BIO CEO
Recently, the Biotech Innovation Organization (BIO) announced a new CEO, John Crowley. Crowley is the co-founder of Amicus…
Evaluation on NGACO Model Finds Spending Reductions Grow Over Time
The United States Centers for Medicare and Medicaid Services (CMS) recently funded a report by NORC at the University of Chicago,…
CMS Issues Interoperability and Prior Authorization Final Rule
Early this year, the United States Centers for Medicare and Medicaid Services (CMS) issued a final rule on Interoperability and…