Publications

Hogan Lovells Publications

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 Draft guidance suggests FDA is looking more closely at clinical trial disclosures

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."

Hogan Lovells Publications

FCA Alert: Medical judgment can be "false" under False Claims Act

For the second time in as many weeks, a federal appellate court has held that a doctor’s medical judgment can be "false."

Hogan Lovells Publications

OIG releases revised and expanded self-disclosure protocol

On April 17, 2013, the Office of Inspector General of the Department of Health and Human Services (OIG) released a revised self-disclosure protocol (SDP) that significantly overhauls the...

Hogan Lovells Publications

Free speech mandates vacating off-label promotion conviction, says Second Circuit

In a split decision raising significant questions for ongoing investigations, company practices, and future prosecutions, the United States Court of Appeals for the Second Circuit vacated a ...

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