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FDA approves a BioFire Diagnostics de novo petition to allow the marketing of its FilmArray Meningitis/Encephalitis Panel, a cereb...[ Price : $8.95]
Rep. Rosa DeLauro urges FDA to remove Bayers controversial Essure contraceptive due to the thousands of adverse events submitted t...[ Price : $8.95]
Federal Register Notice: FDA submits to the Office of Management and Budget a collection of information in a guidance on formal me...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on a guidance on formal dispute resolution and appeals a...[ 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...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Integrated Summary of Effectiveness.[ Price : $8.95]
Amplifying his demand for CDRH director Jeffrey Shurens resignation, 510(k) critic and morcellator activist Hooman Noorchashm comp...[ Price : $8.95]
University of Florida law professor Lars Noah says FDA is using guidance documents when it would be better to use notice-and-comme...