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FDA Clears BioFure Meningitis/Encephalitis Test Panel

[ Price : $8.95]

FDA approves a BioFire Diagnostics de novo petition to allow the marketing of its FilmArray Meningitis/Encephalitis Panel, a cereb...

FDA Should Remove Bayers Essure from Market: Rep. DeLauro

[ Price : $8.95]

Rep. Rosa DeLauro urges FDA to remove Bayers controversial Essure contraceptive due to the thousands of adverse events submitted t...

Info on Formal Sponsor Meetings Sent to OMB

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Federal Register Notice: FDA submits to the Office of Management and Budget a collection of information in a guidance on formal me...

Info on Dispute Resolution Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on a guidance on formal dispute resolution and appeals a...

FDA Clears Carestream ECG Viewer

[ Price : $8.95]

FDA clears a Carestream 510(k) to allow diagnostic reading of ECG waveforms on desktop displays and mobile tablets using its Vue M...

Guidance on Integrated Summaries of Effectiveness

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Federal Register Notice: FDA releases a guidance: Integrated Summary of Effectiveness.

Shurens Lawyer-wife is Conflict of Interest: Activist

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Amplifying his demand for CDRH director Jeffrey Shurens resignation, 510(k) critic and morcellator activist Hooman Noorchashm comp...

FDA Relying Too Heavily on Guidances: Professor

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University of Florida law professor Lars Noah says FDA is using guidance documents when it would be better to use notice-and-comme...

Lilly Given Breakthrough Status for Breast Cancer Therapy

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FDA grants Eli Lilly a breakthrough therapy designation for abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for pa...

Ostroff Praises Forensic Chemistry Center

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FDA acting commissioner Stephen Ostroff praises the work of the agencys Forensic Chemistry Center over the last 25 years and pledg...