Deferred Prosecution Agreements, Food and Drug Administration (FDA)

Recent DOJ Consumer Protection Branch Cases Highlight the Branch’s Enforcement Priorities

Oberheiden P.C. on 10/6/2022

The U.S. Department of Justice’s (DOJ) Consumer Protection Branch works with other branches and federal law enforcement agencies to investigate and prosecute civil and criminal violations of the nation’s consumer protection...more

The DOJ’s Focus on Clinical Trial Enforcement: An Ounce of Prevention Is Better Than an Enforcement Action Cure

Orrick, Herrington & Sutcliffe LLP on 4/27/2022

In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...more

Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

Skadden, Arps, Slate, Meagher & Flom LLP on 9/9/2021

Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more

Blog: Q3 Government Settlements Round-Up: Life Sciences

Cooley LLP on 10/1/2019

The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in July – September 2019....more

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

Skadden, Arps, Slate, Meagher & Flom LLP on 9/28/2017

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

Deferred Prosecution Agreements › Food and Drug Administration (FDA)

Recent DOJ Consumer Protection Branch Cases Highlight the Branch’s Enforcement Priorities

The DOJ’s Focus on Clinical Trial Enforcement: An Ounce of Prevention Is Better Than an Enforcement Action Cure

Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

Blog: Q3 Government Settlements Round-Up: Life Sciences

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

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