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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...

Alexion Pharmas Strensiq OKd for Hypophosphatasia

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FDA approves an Alexion Pharmaceuticals NDA for Strensiq (asfotase alfa), the first approved treatment for perinatal, infantile an...

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...

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...

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...

Donnelly Touts Medical Innovation Agenda

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Sen. Joe Donnelly says he is backing a number of bills in what he calls a Medical Innovation Agenda.