News & Analysis as of

Drug Treatment Pharmaceutical Industry

Lathrop GPM

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

Lathrop GPM on

The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more

Nelson Hardiman, LLP

Too Much Of A Good Thing?

Nelson Hardiman, LLP on

F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more

Vicente LLP

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

Vicente LLP on

On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more

Manatt, Phelps & Phillips, LLP

[Webinar] Reimagining Medicine: Can Policy Keep Pace With Scientific Advances? - February 1st, 1:00 pm - 2:00 pm ET

Speakers From AbbVie, National Institutes of Health, National Organization for Rare Disorders, NYU Grossman School of Medicine and Verily Share Insights on How Medical Innovation Is Disrupting Policy—and What Needs to Come...more

Vicente LLP

What is the Process for Federal Psilocybin Registration?

Vicente LLP on

We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of...more

Faegre Drinker Biddle & Reath LLP

FDA’s Revocation of the Hydroxychloroquine and Chloroquine EUA May Test the Limits of PREP Act Immunity

On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

Patrick Malone & Associates P.C. | DC Injury...

$14k to treat iron-poor blood? That’s rich. As is politicians’ health care frenzy.

Iron poor blood? For many of a certain age, mere mention of that phrase conjures the major advertising campaigns of yore for a popular, over-the-counter nostrum called Geritol. The tonic is still around and sells for less...more

McDermott Will & Emery

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

McDermott Will & Emery on

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

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