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Follow-on Bills Have No Value: Researchers

[ Price : $8.95]

A study published in the New England Journal of Medicine urges that legislation for an approval pathway for follow-on biologics be...

DTC Ads Dont Help Consumers Make Good Decisions: Study

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UCLA researchers say that drug companies should voluntarily change DTC ads so they provide consumers more information needed to ma...

SpinalMotion Files PMA for Lumbar Disc

[ Price : $8.95]

SpinalMotion submits a PMA for the Kineflex lumbar artificial disc.

Regs Corrected on Genetically Engineered Animals

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Federal Register Notice: FDA corrects the heading in 21 CFR 500-599, page 359 on new animal drugs in genetically engineered animal...

Guidance on Registration for Tobacco Establishments

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Federal Register Notice: FDA releases a guidance Registration and Product Listing for Owners and Operators of Domestic Tobacco Pro...

An FDA Ear Full on Social Media and Need for Guidance

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Medical product marketers and advertising-related entities urge FDA to develop guidance on allowing more innovative use of Interne...

Pfizer Neurontin Trials Selectively Reported Outcomes: Study

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A New England Journal of Medicine study says that in published reports on 20 company-funded studies of off-label uses for Neuronti...

Age Range Expanded for CSL Flu Vaccine

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FDA says that a 2009 H1N1 flu vaccine produced by CSL Ltd. may be used in children over age six months as well as adults.

Avanir Working on Complete Response for Zenvia

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Avanir Pharmaceuticals says it will submit a complete response in the second quarter of 2010 to address a 10/06 approvable letter ...

States Becoming More Active in Drug, Device Regulation

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A Skadden legal memorandum says that state attorneys general are mining FDA Warning Letters for leads to state investigations and ...