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FDA Forced to Defend Tobacco Regulation

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FDA is being forced to defend new restrictions on tobacco product advertising and promotion being challenged in a federal lawsuit ...

Public Citizen Says Other Drugs Affect Oxycodone

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Public Citizen cautions that 35 drugs can increase toxicity or reduce the effect of oxycodone when taken with it.

FDA Wants More Data on Asthma Drug

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FDA says more clinical data is needed before it will approved SkyePharmas NDA for Flutiform (fluticasone propionate/formoterol fum...

510(k) User Fee Guidance Out

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FDA publishes a guidance with frequently asked questions on 510(k) user fees and refunds.

Info on Prescription Drug Marketing Act Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on the Prescription Drug Marketing Act of 1987 to the Offi...

OMB OKs Info on Importers Entry Notice

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Federal Register Notice: The Office of Management and Budget approves FDAs collection of information entitled, Importers Entry Not...

FDA Sends Info on Tobacco Establishment Registration to OMB

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Federal Register Notice: FDA submits a proposed collection of information on tobacco product establishment registration to the Off...

Guidance on Labeling Non-Rx Drug Products

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Federal Register Notice: FDA releases a guidance on the labeling of non-prescription human drug products marketed without an appro...