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Regulatory Oversight › Civil Monetary Penalty › Food and Drug Administration (FDA)

Parker Poe Adams & Bernstein LLP

Is FDA's Civil Money Penalty Authority Dead, and If So, What Does It Mean for Life Sciences Companies?

Parker Poe Adams & Bernstein LLP on

Does the recent decision in a federal district court in Texas, finding that the U.S. Food and Drug Administration’s tobacco civil money penalty authority is unconstitutional, mean the end of the federal agency bringing...more

Troutman Pepper Locke

FDA Maintains Heightened Enforcement Against Sellers of Illegal E-Cigarettes

Troutman Pepper Locke on

In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent...more

Goodwin

FDA Releases Draft Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

Goodwin on

Last week, FDA published its draft guidance on civil money penalties relating to the ClinicalTrials.gov data bank to the federal register. The guidance addresses how the FDA Centers (CDER, CBER, and CDRH, for drug,...more

Hogan Lovells

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures

Hogan Lovells on

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank." ...more

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