Comic Dimitri Martin notes, “I’m sorry” and “I apologize” mean the same thing — unless you are speaking to the widow at a funeral
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adverse event
FDA Proposes That Adverse Event Reports Be Submitted Electronically
By Sean Wajert on
Posted in Articles, Drug and Device
The Food and Drug Administration last week proposed new rules that would require adverse event reports related to approved devices, drugs and biologic…
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State Appellate Accutane Decision Reverses Verdict
By Sean Wajert on
Posted in Articles, Drug and Device
The New Jersey Superior Court issued an interesting decision in the Accutane litigation last week. See McCarrell v. Hoffman-La Roche, Inc., And Roche …
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FDA To Hold Workshop On “Sentinel” Initiative
By Sean Wajert on
Posted in Articles, Drug and Device
The Food and Drug Administration is holding a public workshop entitled Sentinel Initiative: Structure, Function, and Scope. The workshop is co-sponsor…
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FDA Releases First Quarterly Safety Signals Report
By Sean Wajert on
Posted in Articles, Drug and Device
The U.S. Food and Drug Administration has posted on its website its first quarterly report listing certain drugs that are being evaluated for potentia…
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FDA Launches Sentinel Initiative
By Sean Wajert on
Posted in Articles, Drug and Device
On May 22, 2008, FDA launched the “Sentinel Initiative” – a new program with the goal of creating and implementing the Sentinel Syst…
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