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Guidance on Biologic E-Submission of Lot Distribution Reports

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Federal Register Notice: FDA releases a draft guidance on electronic submission of lot distribution reports for applicants with ap...

FDA Clears Nonin Medical Finger Pulse Oximeter

[ Price : $8.95]

FDA clears Nonin Medicals Nonin Model 3231 OEM/eHealth finger pulse oximeter to measure oxygen saturation and pulse rate.

Justice Dept. Calls Out PhRMA in Off-label Case

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The U.S. Department of Justice disputes a Pharmaceutical Research and Manufacturers of America brief asking a California federal c...

FDA Clears Vital Connect HealthPatch MD Home Monitor

[ Price : $8.95]

FDA clears a Vital Connect 510(k) for its HealthPatch MD biosensor for monitoring patients at home.

Court Nixes Request to Reverse $9 Billion Actos Damage Award

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A Western District of Louisiana federal judge rejects a Takeda Pharmaceutical and Eli Lilly request to reverse a $9 billion puniti...

FDA OKs Expanded Indication for Gaucher Disease Therapy

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FDA approves an expanded indication for Pfizer and Protalix BioTherapeutics Elelyso (taliglucerase alfa) for injection for treatin...

FDA OKs InnoPharma Dacogen Generic

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FDA approves an InnoPharma ANDA for decitabine for injection, a generic of Eisais Dacogne, indicated for treating patients with my...

FDA Denies Petition Seeking Tighter Megace Generic Bioequivalence

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FDA denies a citizen petition seeking tighter bioequivalence recommendations for generic versions of Bristol-Myers Squibbs Megace ...

Researchers Argue for Changes to QALY Cost-effectiveness Measure

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Tufts University researchers call for an update to the decades-old $50,000 quality-adjusted life-year (QALY) benchmark used in cos...

NCPDP Concerned About Non-traditional Drug Naming

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The National Council for Prescription Drug Programs tells FDA it has concerns about the agencys recent decision to give biological...