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Features

Drug Marketing to Doctors: Changes May Be On the Way Image

Drug Marketing to Doctors: Changes May Be On the Way

Janice G. Inman

The cornerstone of many FDA enforcement actions against pharmaceuticals manufacturers in recent years has been the charge that they have "misbranded" their pharmaceutical products by promoting them for uses not approved by the FDA. Now, the Second Circuit has thrown the concept of criminal liability for misbranding by means of off-label-use promotion into turmoil.

Verdicts Image

Verdicts

ALM Staff & Law Journal Newsletters

Analysis of two important rulings.

Features

Drug & Device News Image

Drug & Device News

ALM Staff & Law Journal Newsletters

A discussion of several key cases.

Med Mal News Image

Med Mal News

ALM Staff & Law Journal Newsletters

Several items of interest.

HITECH and HIPAA Enforcement Activities Image

HITECH and HIPAA Enforcement Activities

ALM Staff & Law Journal Newsletters

The OCR is putting new emphasis on enforcing patient privacy rights since the passage of HITECH in 2009. A look at four settlement agreements.

Features

Filing Whistleblower Actions to Avoid Peer Review Image

Filing Whistleblower Actions to Avoid Peer Review

David M. Axelrad, Peder K. Batalden & H. Thomas Watson

The California Supreme Court has taken a keen interest in the peer-review process in recent years. Here's why.

Undoing Pliva Inc. v. Mensing Image

Undoing Pliva Inc. v. Mensing

Josh Becker & Travis Thompson

This article examines the relationship between <i>Pliva</i> and the Patient Safety and Generic Labeling Improvement Act, and discusses the potential ramifications for generic drug manufacturers should the Act be signed into law.

Verdicts Image

Verdicts

ALM Staff & Law Journal Newsletters

Recent rulings of importance.

Features

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Med Mal News

ALM Staff & Law Journal Newsletters

All the latest news.

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Drug & Device News

ALM Staff & Law Journal Newsletters

A look at what's new.

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