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Not With A Bang, But A Whimper . . . FDA Capitulates On Off-Label Regulation

Not With A Bang, But A Whimper . . . FDA Capitulates On Off-Label Regulation

Forbes

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First Amendment takes center stage in DTC price fight

First Amendment takes center stage in DTC price fight

Biopharma Dive

First Amendment

DTC advertising

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The FDA and Off-Label Promotion: First Amendment Considerations Addressed (and Rejected) in FDA Memorandum

The FDA and Off-Label Promotion: First Amendment Considerations Addressed (and Rejected) in FDA Memorandum

FDA Law Blog

First Amendment

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Blame the FDA for missing-in-action off-label guidelines? Nope, say two lawmakers. It's the HHS

Blame the FDA for missing-in-action off-label guidelines? Nope, say two lawmakers. It's the HHS

Fierce Pharma

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Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future?

Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future?

FDA Law Blog

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Another Court Weighs In on Whether Off-Label Promotion is Per Se Illegal; Jury Finds Both Defendants Not Guilty on All Counts

Another Court Weighs In on Whether Off-Label Promotion is Per Se Illegal; Jury Finds Both Defendants Not Guilty on All Counts

FDA Law Blog

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Amarin and FDA near settlement on off-label free speech, ask court for 30 more days

Amarin and FDA near settlement on off-label free speech, ask court for 30 more days

Fierce Pharma

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Pacira sues for free speech; FDA pulls off-label warning letter. What gives?

Pacira sues for free speech; FDA pulls off-label warning letter. What gives?

Fierce Pharma Marketing

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A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion

A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion

FDA Law Blog

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How The Feds Discourage Prescription Drug Competition

How The Feds Discourage Prescription Drug Competition

Forbes

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You're free to speak, FDA tells Amarin in bid to deflate free-speech suit

You're free to speak, FDA tells Amarin in bid to deflate free-speech suit

Fierce Pharma

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FDA Tries to Blunt Amarin’s Free-Speech Lawsuit Over Off-Label Info

FDA Tries to Blunt Amarin’s Free-Speech Lawsuit Over Off-Label Info

WSJ Pharmalot

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Secret doctor letter shows Amarin's true 'free speech' leanings

Secret doctor letter shows Amarin's true 'free speech' leanings

Fierce Pharma Marketing

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To What Extent Should a Drug Maker be Allowed to Convey Off-Label Info?

To What Extent Should a Drug Maker be Allowed to Convey Off-Label Info?

WSJ Pharmalot

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Amarin sues U.S. FDA on free speech grounds over off-label speech

Amarin sues U.S. FDA on free speech grounds over off-label speech

Yahoo/Reuters

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Back to first principles: a new model for the regulation of drug promotion

Back to first principles: a new model for the regulation of drug promotion

Drug and Device Law

First Amendment

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Report claims FDA is behind the times on employees' free speech

Report claims FDA is behind the times on employees' free speech

BioPharma Dive

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FDA Proposal Spurs Fight Over Free Speech and Patient Safety

FDA Proposal Spurs Fight Over Free Speech and Patient Safety

WSJ Pharmalot

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Free speech, PhRMA? Not in this off-label marketing case, feds say

Free speech, PhRMA? Not in this off-label marketing case, feds say

Fierce Pharma Marketing

Millennium Pharmaceuticals

whistleblower lawsuits

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PhRMA jumps into Integrilin off-label case, free-speech arguments at the ready

PhRMA jumps into Integrilin off-label case, free-speech arguments at the ready

Fierce Pharma Marketing

Schering Plough

Millennium Pharmaceuticals

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