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FDA Clears Protein Polymer PVA Foan 510(k)

[ Price : $8.95]

FDA clears a Protein Polymer Technologies 510(k) to market its PVA foam embolization convenience kits for peripheral vascular indi...

2nd Judge Rejects FDA Labeling Preamble on Preemption

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A second judge rejects FDAs controversial preamble to its new drug labeling regulations asserting preemption over state law in fai...

Beitz Named ODE III Director

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CDER names Office of Drug Evaluation III acting director Julie Beitz as permanent director.

Waxman Continues Push for Phenylephrine Study

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Rep. Henry Waxman again asks FDA to study phenylephrines effectiveness as an oral decongestant.

NeuroScience Warned On Unapproved New Drugs

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FDA warns NeuroScience, Inc., it is distributing unapproved new drugs that also are misbranded.

Miami Man Sentenced Over Counterfeit Drugs

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A federal judge sentences Julio Cesar Cruz to over 13 years in prison for his role in a multi-million dollar counterfeit drug dist...

OMB OKs Info on Emergency Use Authorization

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Federal Register Notice: The Office of Management and Budget approves FDAs collection of information on emergency use authorizatio...

OMB Approves Info on Sample/Protocol Requests

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Federal Register Notice: The Office of Management and Budget approves a collection of information on requests for samples and prot...

Comments Sought on Exempting Cranial Orthosis Devices

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Federal Register Notice: FDA receives a petition requesting exemption from premarket notification requirements for cranial orthosi...

FDA OKs Delayed-release Nexium Suspension

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FDA approves a new delayed-release oral suspension formulation for AstraZenecas proton pump inhibitor Nexium.