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Former FDA Official Outlines Needed Improvements at Agency

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A former FDA official calls out the agency over a couple of recent approvals that defy common sense and lack scientific proof that...

ICD Protocol, Implementation Weaknesses: Study

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Researchers say they found that current ICDs are vulnerable to computer attacks that could compromise patient safety.

CGMP Deviations Found in Spains Interquim

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FDA warns Spains Interquim about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Senate Amendment Seeks to Prevent Generic Drug Delays

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Senate Judiciary Committee members led by ranking member Patrick Leahy (D-VT) introduce a bipartisan amendment to prevent pharmace...

Appeals Court Upholds Nexium Pay for Delay Decision

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Two Knobbe Martens attorneys outline reasons why a federal appeals court upheld a lower court jury ruling that a reverse payment t...

FDA Working with Stakeholders on Opioid Use: Throckmorton

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CDER deputy director Douglas Throckmorton says FDA is working well with stakeholders to achieve goals on the safe and appropriate ...

Regulators Look for Biosimilar Scientific Alignment: FDAer

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Office of New Drug associate director Leah Christl says that biosimilar companies should be aware of various regulators requiremen...

Latest FDA Warning Letters

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In its latest release of Warning Letters, FDA cites Interquim, a Spanish active pharmaceutical ingredient maker.

Class 2 for Computerized Concussion Assessment Aids

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Federal Register Final Order: FDA classifies Computerized Cognitive Assessment Aids for Concussion into Class II (special controls...

Biomarker Evidentiary Criteria Framework Released

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The Foundation for the National Institutes of Health issues its Framework for Defining Evidentiary Criteria for Biomarker Qualifi...