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3 Clinical Outcome Assessment Grants Awarded

[ Price : $8.95]

FDA awards three grants under a pilot program to support developing publicly available clinical outcome assessments and related en...

FDA Revokes Zika Test Emergency Authorization

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Federal Register notice: FDA revokes an Emergency Use Authorization issued to Siemens Healthcare Diagnostics for the Advia Centaur...

Abernathy Promotes Modern IT for Product Review

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FDA principal deputy commissioner Amy Abernathy says the agency will announce within a month a plan to modernize its information t...

Janssen Files Tremfya sBLA for Psoriatic Arthritis

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Janssen Pharmaceutical files a supplemental BLA for Tremfya (guselkumab) for treating adult patients with active psoriatic arthrit...

FDA-483 Posted on Hybrid Pharma Inspection

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FDA posts a Form FDA-483 citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspec...

Comments Sought on Powered Stretcher Exemption

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Federal Register notice: FDA seeks comments on a petition requesting exemption from the premarket notification requirements for po...

Impax Ursodiol Capsules Withdrawn Over BE Data

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Federal Register notice: FDA withdraws approval of an Impax ANDA for ursodiol capsules (XXX INSERT XXX)USP, 300 mg, due to agency ...

Gottlieb Added to FasterCures Board

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Former FDA Commissioner Scott Gottlieb joins FasterCures advisory board.

FDA Clears Zimmer JuggerStitch Meniscal Repair

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FDA clears a Zimmer Biomet Holdings 510(k) for the JuggerStitch meniscal repair device.

Qfix Encompass 15-Channel Head Coil Cleared

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FDA clears a Qfix 510(k) for the Encompass 15-Channel Head Coil, a diagnostic imaging device for use with the Encompass MR SRS Imm...