News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Criminal Penalties

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.

6 FDA Audit Defense Strategies

Oberheiden P.C. on

An audit by the Food and Drug Administration (FDA) can uncover violations of federal food and drug regulations, as well as the Food, Drug, and Cosmetic Act (FD&C Act). Those violations can lead to administrative, civil, or...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - September 2021

The September 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses a recent non-precedential Trademark Trial and Appeal Board decision regarding intent-to-use applications covering CBD products currently...more

Health Care Compliance Association (HCCA)

Opioid manufacturer pleads guilty to fraud

Compliance Today (February 2021) - Purdue Pharma LP pleaded guilty to three felony offenses: “one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two...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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