News & Analysis as of

Criminal Penalties Food and Drug Administration (FDA)

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

Foley Hoag LLP - Cannabis and the Law

The Cannabis Rescheduling Recommendation: What it Means and What’s Next

In light of the August 30, 2023 historic recommendation from the U.S. Department of Health and Human Services (HHS) to reschedule cannabis to Schedule III, a multidisciplinary group of attorneys from Foley Hoag’s nationwide...more

ArentFox Schiff

Investigations Newsletter: Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations

ArentFox Schiff on

Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations - On January 4, 2023, a criminal information was filed in the Southern District of Illinois, in which Jet Medical Inc. (Jet), a medical device...more

Oberheiden P.C.

7 Keys to Effective FDA Audit Defense Strategies

Oberheiden P.C. on

U.S. Food and Drug Administration (FDA) audits can uncover violations of the Food, Drug, and Cosmetic Act (FD&C Act) and other federal food and drug laws and regulations. Those violations can lead to administrative, civil, or...more

Oberheiden P.C.

Prescription and Medication Counterfeiting Defense

Oberheiden P.C. on

21 U.S.C. § 331: Selling Counterfeit Drugs - Under Section 331, it is illegal to sell counterfeit drugs in interstate commerce. Because this includes online sales, the “interstate commerce” element is very easy to...more

Cooley LLP

DOJ Previews Enforcement Policies Aimed at Clinical Trial Fraud

Cooley LLP on

On December 9, 2021, one of the nation’s top healthcare prosecutors made clear that clinical trial fraud will be a major enforcement priority of President Joe Biden’s Department of Justice. Speaking at the Food and Drug Law...more

Fox Rothschild LLP

The Regulation Of Hemp, Hemp Derivatives And CBD In Animal Products

Fox Rothschild LLP on

If you are trying to navigate the space where hemp products intersects with animal products, it can be unclear as to which authority to turn to for guidance. In the United States, FDA, FTC, DEA and USDA share governance over...more

Perkins Coie

Industry Insights: States Have Beef With Labeling of Meat Alternatives

Perkins Coie on

Across the country, states are enacting laws related to the labeling of meat alternative products. Missouri, Mississippi, Arkansas, and Louisiana have passed laws restricting the ability of vegetable-based proteins and other...more

Skadden, Arps, Slate, Meagher & Flom LLP

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

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