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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
FDA
free speech
off-label
Janet Woodcock
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First Amendment takes center stage in DTC price fight
First Amendment takes center stage in DTC price fight
Biopharma Dive
free speech
First Amendment
drug pricing
Donald Trump
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
FDA
off-label
First Amendment
free speech
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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
FDA
off-label
free speech
HHS
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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
FDA
off-label
free speech
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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
FDA
off-label
FTC
devices
free speech
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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
Amarin
FDA
off-label
free speech
Vascepa
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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
Pacira
FDA
off-label
free speech
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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
FDA
off-label
Vascepa
free speech
Amarin
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How The Feds Discourage Prescription Drug Competition
How The Feds Discourage Prescription Drug Competition
Forbes
competition
free speech
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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
FDA
Amarin
free speech
Vascepa
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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
FDA
free speech
Amarin
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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
Amarin
free speech
FDA
Vascepa
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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
off-label
free speech
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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
Amarin
FDA
free speech
off-label
Vascepa
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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
off-label
First Amendment
free speech
FDA
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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
FDA
free speech
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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
patients
FDA
free speech
off-label
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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
off-label
free speech
PhRMA
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
PhRMA
off-label
free speech
Integrilin
Merck
Schering Plough
Millennium Pharmaceuticals
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