News & Analysis as of

Department of Justice (DOJ) › Enforcement Guidance › Food and Drug Administration (FDA)

Latham & Watkins LLP

Key Insights on President Trump Executive Order Limiting Criminal Enforcement of Regulatory Offenses

Latham & Watkins LLP on

The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more

Foley & Lardner LLP

DOJ Issues Guidelines for Enforcement Related to Off-Label Promotion

Foley & Lardner LLP on

On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more

McDermott Will & Schulte

Guidance on Guidance: DOJ Limits Use of Agency Guidance Documents in Civil Enforcement Cases

McDermott Will & Schulte on

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more

Akin Gump Strauss Hauer & Feld LLP

DOJ Limits Use of Guidance Documents in Affirmative Civil Enforcement Actions

Akin Gump Strauss Hauer & Feld LLP on

On January 25, 2018, the Associate Attorney General directed the Department of Justice (DOJ) not to rely on agency guidance documents to establish a violation in affirmative civil enforcement (“ACE”) cases. She issued the...more

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