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Summary Judgment in Class 3 Device Case

[ Price : $8.95]

Attorney Michelle Yeary analyzes a medical device case that was dismissed by an Alabama federal court on both medical causation an...

FDA Adds 1 Bulk Drug for Compounding, Rules Out 4 Drugs

[ Price : $8.95]

FDA proposes to add one active ingredient to the bulk drug substance list for drug compounding and proposes not to add four other ...

Fresenius Kabi to Pay $50 Million in FDA Records Case

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The Justice Department says Fresenius Kabi Oncology was ordered to pay $50 million in fines and forfeitures after pleading guilty ...

Principal Deputy Commissioner Abernethy Leaving FDA

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FDA principal deputy commissioner and acting chief information officer Amy Abernethy announces she will be leaving the agency in t...

Pfizer Arthritis Drug Has Small Efficacy, Safety Concerns: FDA

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An FDA advisory committee briefing document says a Pfizer BLA for osteoarthritis drug tanezumab subcutaneous injection shows (XXX ...

AstraZeneca Covid Vaccine has 79% Efficacy

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AstraZeneca interim data show that its Covid-19 vaccine efficacy 79% at preventing symptomatic Covid-19 and 100% efficacy at preve...

FDA Warns Firms Illegally Selling CBD Products

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FDA sends Warning Letters to two companies for selling OTC products labeled as containing cannabidiol.

Gonorrhea Drug Development Public Workshop

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FDA announcess 4/23 virtual public workshop entitled Development Considerations of Antimicrobial Drugs for the Treatment of Gonorr...

First Machine-learning Covid Screening Device Authorized

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FDA grants Tiger Tech Solutions an emergency use authorization for the first machine learning-based Covid-19 non-diagnostic screen...

Recovery Force Leg Mover/Compressions Device Cleared

[ Price : $8.95]

FDA clears a Recovery Force 510(k) for the Movement and Compressions System, a data-driven mobility measurement device designed fo...