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FDA Grants Fast Track for Novavax for RSV F-Protein Vaccine

[ Price : $8.95]

FDA grants Novavax fast track status for its RSV F-Protein nanoparticle vaccine candidate.

Groups Back FDA Drug Compounding Enforcement

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Six stakeholder groups praise FDAs risk-based approach to regulating drug compounding.

FDA Collection of Info on Risk/Benefit Perception to OMB

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Federal Register Notice: FDA submits a proposed collection of information on risk and benefit perception scale development to the ...

CDRH Extends UDI Labeling Compliance Date

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CDRH extends until 9/24/16 the compliance date for unique identification system labeling requirements for medical devices meeting ...

FDA Seeks Drug Risk/Benefit Perception Measures

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FDA proposes drug advertising research to give it a pool of measurement tools to evaluate consumer perceptions of risk and benefit...

FDA Denies Kuvan Bioequivalence Petition

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FDA denies a petition to permit a drug company to submit an ANDA demonstrating bioequivalence to BioMarins Kuvan sold in Israel ra...

Mallinckrodt Asks Court to Nix FDA Action on Generic Concerta

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Mallinckrodt asks a Maryland federal court to stop FDA from reclassifying its generic form of Concerta from AB to BX.

Failure to Warn Decision May be Meaningless: Blog

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The Drug and Device Law Blog says a New Jersey court decision allowing a Reglan failure-to-warn claim to go forward will likely no...

Justice Dept. Indicts Vascular Solutions on Unapproved Device

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The U.S. Justice Department files an indictment charging Vascular Solutions and its chief executive officer, Howard Root, with sel...

FDA Partial Hold on CytRx Trials with Aldoxorubicin

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FDA issues a partial clinical hold on CytRx Corp. and its clinical trials for cancer therapy aldoxorubicin have been placed on par...