The Dangers of Essure Removal

Essure is marketed as the only permanent birth control device that doesn’t require a surgery. But while implanting the device…

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The Significance of The FDA’s Essure Black Box Warning

 

Watch virtually any drug commercial long enough and, after the deliriously happy looking actors are done twirling in a meadow,…

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Generic Drug Labeling: FDA Provides Guidance For Label Updates

Just over five years ago, in June 2011, the U.S. Supreme Court decided PLIVA, Inc. v. Mensing,[1] a case which…

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E-Cigarettes: The New Kink in the Fight Against Tobacco

While the anti-tobacco movement has made major legislative strides over the years in the fight against death and disease caused…

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New Rules for Clinical Trial Transparency: Did the NIH and FDA Provide a Solution or Merely Identify a Problem?

Clinical trials—or the lack thereof—often play a central role in cases involving dangerous drugs and medical devices. If and when…

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Proposed FDA Rule Allows Generic Drug Manufacturers to Update Labeling

After much anticipation, the U.S. Food and Drug Administration (FDA) has taken action to place responsibility on generic drug manufacturers…

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Medical Devices in the Market: Are they Safe, or Just Similarly Dangerous?

Efficiency and speed is valued when bringing new medical devices to the market, but what remains relatively unknown are the…

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FDA User Fee Legislation: Lowering Consumer Costs by Increasing the Availability of Generic Drugs on the Market

On May 30, 2012, the U.S. House of Representatives passed H.R. 5651 in a 387-5 vote, following Senate approval of…

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The Continued Fight to Undo Mensing

Last month, I highlighted the mounting pressure to remedy the inconsistencies and inequities resulting from the Supreme Court’s decision in…

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A Call to Restore the Rights of Generic Drug Consumers

Warning labels on generic drugs have garnered a lot of attention recently, and for good reason.  In PLIVA, Inc. v.…

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