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FDA Early Alert on Fresenius Pump Software Updates

[ Price : $8.95]

Citing potentially lethal risk, an FDA Early Alert says Fresenius Kabi is recommending updates to some software for its Ivenix Inf...

FDA Warns Against Using Epinephrine Nasal Solution

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An FDA alert warns healthcare professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs and Endo US...

FDA Complete Response on Ataras Ebvallo

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FDA sends Atara Biotherapeutics a complete response letter on its BLA for Ebvallo (tabelecleucel), a monotherapy treatment for adu...

Anti-Neuropathy Guidance for Cancer Drugs

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FDA publishes a draft guidance on developing drugs to prevent and treat cancer-related chemotherapy-induced peripheral neuropathy.

FDA Policy Head Lands at King & Spalding

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King & Spalding hires former FDA associate commissioner for policy Lauren Roth as a partner on the FDA and Life Sciences team.

QS Violations at Xoran Technologies

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FDA warns Ann Arbor, MI-based Xoran Technologies about Quality System Regulation violations in its manufacturing of adulterated an...

8 Observations in Phillips Precision Inspection

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FDA warns Elmwood, NJ-based Phillips Precision about eight Quality System violations in its contract manufacturing of orthopedic i...

AdvaMed Trial Participation Snapshot Comments

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AdvaMed recommends ways in which FDA can improve its medical device trial participation snapshot program.

Former McKinsey Exec Pleads Guilty in Opioid Case

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The Justice Department says a former McKinsey executive pleaded guilty to knowingly destroying information central to the governme...

Lillys Omvoh Wins Expanded Approval

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FDA approves Eli Lillys Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohns disease in adults.