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FDA Clears NuVasives MAGEC Spinal Implant

[ Price : $8.95]

FDA clears a NuVasive 510(k) for its MAGEC system to be surgically implanted using its Reline posterior fixation system for treati...

FDA OKs Label Extension for Tagrisso Companion Diagnostic

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FDA approves a label extension for Roches EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Ze...

Court Allowing FDA to Regulate Medical Practice: Attorneys

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Attorneys Anne Walsh and Andrew Hull says a recent 9th Circuit appeals court decision gives FDA an opportunity to regulate the pra...

FDA Clinical Hold on Alcobra ADHD Trial

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FDA places a clinical hold on an Alcobra Ltd. clinical trial called MEASURE that is evaluating its investigational drug metadoxine...

Comments Sought on Dietary Supplement GMP Recordkeeping

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Federal Register Notice: FDA announces an opportunity for public comment on information collection related to an extension of Curr...

Notice on West Nile Virus Guidance Corrected

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Federal Register Notice: FDA corrects a 9/13 notice on the availability of a guidance on Use of Nucleic Acid Tests To Reduce the R...

Notice on Biosimilar Public Meeting Corrected

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Federal Register Notice: FDA corrects a 9/19 notice on Biosimilar User Fee Act; Public Meeting to correct a date reference when th...

FDA Clears Becton Dickinson Plasma Blood Collector

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FDA clears a Becton Dickinson 510(k) for the BD Vacutainer Barricor plasma blood collection tube, a next generation blood collecti...

Information Security Weaknesses in 7 FDA Systems: GAO

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FDA says it has implemented 12 of 15 GAO recommendations for tightening its cybersecurity covering seven agency systems.

Group Wants Triclosan Banned from Toothpaste

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The Cornucopia Institute urges FDA to ban the use of triclosan in toothpaste, as it did in hand soaps earlier this month.