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Endo Paying $1.5 Billion Fines, Forfeitures

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Endo is ordered to pay $1.85 billion in fines and forfeitures after pleading guilty to introducing misbranded Opana ER into inters...

LDT Final Rule Legal Challenges Likely: Attorneys

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Six Hogan Lovells attorneys comprehensively analyze the new FDA final rule on laboratory-developed tests and predict industry stak...

Hearing to Grill FDA Center Directors

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The House Energy and Commerce Committee announces a 5/22 hearing titled Check Up: Examining FDA Regulation of Drugs, Biologics, an...

FDA OKs Breakthrough Colorectal Cancer Test

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FDA approves Geneoscopys colorectal cancer stool-based screening test ColoSense for those aged 45 years and older with an average ...

Lilly Gets 6/10 Panel Date for Alzheimers BLA

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FDA announces a 6/10 Peripheral and Central Nervous System Drugs Advisory Committee meeting to vote on an Eli Lilly BLA for Alzhei...

Guide on REMS Logic Model

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Federal Register notice: FDA makes available a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With A...

House Committee Pressures FDA on China Oversight

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The House Oversight Committee puts pressure on FDA and its oversight of imported Chinese and other foreign active pharmaceutical i...

Multiple Violations in Bioptimal Inspection

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FDA warns Chinas Bioptimal International about multiple violations at a Singapore facility manufacturing two unapproved catheters....

CDRH Product Evaluation/Quality Office Modified

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Federal Register notice: FDA announces that CDRH Office of Product Evaluation and Quality has modified its organizational structur...

FDA OKs TE Code for Paclitaxel Suspension

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FDA approves an AB therapeutic equivalence code for cancer drug paclitaxel suspension and tells HBT Labs it must formally apply fo...