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Anti-Neuropathy Guidance for Cancer Drugs

[ Price : $8.95]

FDA publishes a draft guidance on developing drugs to prevent and treat cancer-related chemotherapy-induced peripheral neuropathy.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

Getinge/Maquet Recalls VasoView HemoPro 2 Devices

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Getinge and its subsidiary Maquet Cardiovascular recall the VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting ...

23 No-Longer-Marketed Generics Withdrawn

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Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they told the agency that the drug prod...

Vanda Can Seek Tradipitant Hearing: FDA Notice

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FDA proposes to deny a Vanda NDA for tradipitant and offers the company an opportunity to seek a commissioners hearing on the deni...