Regulatory

Yahoo! Submits Document to FDA Social Media Docket and Status of Submissions


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Facebook and Web Pages - What Pharma and FDA Need to Know


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Interesting History at FDA as Alliance for a Stronger FDA Goes to Bat for Bigger Agency Budget


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Weekly Roundup - 3/4/10

We creep closer to Spring.

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What’s Cookin’ Good Lookin’? FDA Issues 17 Warning Letters on 22 Products re Labeling

In what may be the first mass mailing of a letter to a manufacturer since the infamous 14 April 2nd Notice of Violation letters sent to pharmaceutical companies regarding paid search, the FDA yesterday notified 17 food manufacturers of 22 label violations on food products

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Another Torrent of Comments to FDA Social Media Docket

My guess is that there is a lag time between the time that comments are actually filed and the time that FDA actually posts them to the rather labor-intensive and not always working correctly Regulations.gov site that houses the comments to the docket for the Part 15 meeting on medical product promotion and the internet and social media.

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FDA Gives Red Light to Ranbaxy for Generic Flomax

The Indian generic firm Ranbaxy was dealt another blow this week as its version of the enlarged prostate drug Flomax was denied approval in the US just as it was about to go to market.

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The Expanding Role of Twitter in Governance

Many of you will recall that in January, I published a White Paper called Twongress:

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Health Care Reform and Its Impact on FDA and Pharma

Last week, the excruciatingly long and unpredictable path of health care reform passed another milestone when

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Avandia 2: Ethical Boogaloo?

GSK is coming under serious fire again from the FDA and Senate, who say the company resorted to scientific flimflammery to keep researchers quiet about Avandia’s safety risks.

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