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FDAs Gold Standard Seen as Yielding to a New Identity

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FDA Matters commentator Steven Grossman sees an identity crisis at FDA as it struggles to uphold its gold standard while advancing...

Guidance on Cancer Vaccines

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Federal Register Notice: FDA releases a guidance, Clinical Considerations for Therapeutic Cancer Vaccines.

Comments Sought on Prescriber Education for Opioid Class

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Federal Register Notice: FDA releases a draft document for comments, Blueprint for Prescriber Education for the Long-Acting/Extend...

Workshop on Surgical Devices

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Federal Register Notice: FDA plans a public workshop 12/2 on evidence development for surgical medical devices and procedures.

Synthon Pharmaceuticals Generic Xyzal Approved

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FDA approves a Synthon Pharmaceuticals ANDA for a generic version of UCB's Xyzal oral solution, indicated for treating indoor and ...

FDA Loses Cigarette Warning First Amendment Challenge

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FDA loses on First Amendment grounds its bid to require cigarette makers to place graphic warnings on their products while a broad...

Hamburg Taps Law Partner as Staff Chief

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FDA commissioner Margaret Hamburg chooses former Zuckerman Spaeder partner Lisa Barclay as her new chief of staff.

Report on Medical Product Shortages

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Federal Register Notice: FDA releases a report on medical product shortages and requests comments.

FDA Conditionally OKs Edwards Expanded Valve Study

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FDA conditionally approves an Edwards Lifesciences expanded study involving its next-generation Sapien XT transcatheter heart valv...

Yersinia Species IVDs into Class 2

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Federal Register Proposed rule: FDA proposes to classify in vitro diagnostic devices for Yersinia species into Class 2 with a guid...