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Commissioner Search Down to 3: BioCentury

[ Price : $8.95]

BioCentury identifies the names of three potential FDA commissioner candidates sent to the White House.

Former Officials Find New Roles After FDA

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Former CDER associate director for genomics Felix Frueh joins NDA Partners as an expert consultant, and former FDA chief of staff ...

medPhoton ImagingRing CT Scan Cleared

[ Price : $8.95]

FDA clears a medPhoton 510(k) for the ceiling-mounted ImagingRing, an in-room cone-beam computed tomography imaging system.

Arthrosurface Toe Fixation Cleared by FDA

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FDA clears an Arthrosurface 510(k) for its BOSS Toe Fixation System for stabilizing the first metatarsal that presents with a dist...

Combination Product Labeling Contents

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Three stakeholders suggest changes to an FDA draft guidance on instructions for use in combination product labeling.

Too Few Antibiotics in Development: Pew Report

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A Pew Charitable Trusts issue brief says there are not enough new antibiotics in the development pipeline to meet the need.

Info Collection Extension for PET Drug GMPs

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Federal Register notice: FDA has submitted to OMB an information collection extension for positron emission tomography Drug GMPs.

Sharpless Supporters More Vocal

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Supporters of FDA acting commissioner Ned Sharpless urge the administration to nominate him as permanent commissioner.

Panel to Discuss Duodenoscope Sterilization

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Federal Register notice: FDA announces an 11/6-7 Advisory Committee meeting to discuss industrial ethylene oxide sterilization of ...

Chromatographic Bioanalysis Guidance

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FDA issues a guidance to make recommendations to sponsors, applicants, and contract research organizations on internal standard re...