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Guidance on Tobacco Product Environmental Assessments

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: National Environmental Policy Act; Environmental Assessments for Tobacco Product...

FDA Stalevo Safety Review Finds No Increased CV Risk

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FDA says a recently concluded drug safety review of a Novartis Parkinson's therapy, Stalevo, has found no clear evidence of an inc...

New CDER Policy on BLA Team Reviews

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A new CDER policy document outlines the procedures in the Office of Biotechnology Products and the Office of Manufacturing Quality...

House Subcommittee Hearing on Diagnostic Tests

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The House Energy and Commerce Committee health subcommittee schedules a 10/29 hearing on Examining the Regulation of Diagnostic Te...

OMB OKs Info on Device Recall

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Federal Register Notice: The Office of Management and Budget approves a collection of information on medical device recall authori...

Anti-mercury Groups Petition FDA on Dental Amalgam

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Several anti-mercury groups petition FDA to revoke certain sections of its dental amalgam rule so that it conforms to the Minamata...

FDA Approves Iroko Pharmaceuticals NDA for Vivlodex

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FDA approves an Iroko Pharmaceuticals NDA for Vivlodex (meloxicam) capsules, a nonsteroidal anti-inflammatory drug for managing os...

OMB OKs Info on MedWatch

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Federal Register Notice: The Office of Management and Budget approves a collection of information on Medwatch.

OMB OKs Info On Device Labeling Regs

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Federal Register Notice: The Office of Management and Budget approves a collection of information on medical device labeling regul...

Comments Sought on IVD Device Studies Guidance

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Federal Register Notice: FDA seeks comments on a guidance on informed consent for in vitro diagnostic device studies using unident...