Two weeks ago, Shire received a warning letter for posting a sponsored testimonial on YouTube without including risk information. Shire was very open when I called them up and admitted that the video was posted by accident and immediately removed when it was brought to the company’s attention.
While I’m not 100 percent positive, it [...]

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In response to last week’s blog about FDA’s announcement that, in future reviews of NDAs, it will ditch approvable and nonapprovable letters for “neutral” complete-review letters, Russ Somma sent an interesting and informative take on the likely effect of the new system on the industry. Somma is president of SommaTech, a pharmaceutical development technology consulting [...]

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Say goodbye and good riddance to FDA approvable letters! And nonapprovables too! Welcome to the new feel-good Center for Drug Evaluation and Research (CDER), where no drug will ever be rejected again.
So is it finally a free-for-all for Big Pharma?
Not quite. If anything, given the agency’s stepped-up policing of safety signals, the drug approval rate [...]

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If there’s one piece of pharma news that should come as no surprise, it’s FDA throwing a new drug back at its maker with a “Try again later.” After all, the agency spent last year handing out “approvable” letters like pharma hands out freebies. That’s why we’re surprised that analysts, reporters, and possibly [...]

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The New York Times likes to give the drug industry a hard time with its (unbranded) scandal of the week series—off-label promoting, suppressing data, that sort of thing. But when the 2008 Pulitzer Prizes were handed out on Monday, the winner for best investigative reporting was a series by the Times that even its harshest [...]

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News flowing from the American College of Cardiology meeting has been dominated by Vytorin. And after the presentation analyzing results yesterday, Miller Tabak analyst Les Fundleyter says, “We’re done for the conference in terms of the important stuff. Vytorin is the story this year.”
So what is Vytorin’s story exactly? Industry watchers say they are still [...]

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Looks like everyone is fair game on the Comedy Central show South Park–even Big Pharma. In one of the show’s funniest and most irreverent episodes to date, Eric Cartman (the potty-mouthed chubby kid with the poof-ball hat) becomes infected with HIV during a routine tonsillectomy. And it turns out nobody cares.
Eric goes on an adventure [...]

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The Supreme Court last Wednesday decided the first of an important series of cases having to do with whether FDA approval and regulation preempts lawsuits at the state level. The case was Riegel v. Medtronic, and it had to do with a balloon catheter that burst during an angioplasty. Though it’s a device case, not [...]

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“FDA Seeks to Broaden Range of Use for Drugs” read a headline in this past weekend’s New York Times. You’d be forgiven if you thought the article was about FDA trying to broaden the use of drugs—but in fact it was about something quite different: a new FDA draft guidance that would change the rules [...]

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Cynthia Phillips (right), director of regulatory advertising at Shire HGT, closed this year’s ePharma Summit with a conversation about managing regulatory risks in the world of Web 2.0. Here are some of her comments:
Is the Web promotional labeling? DDMAC does not want to tell us what it is thinking; it just wants to hit us [...]

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