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Former NECC Ops Director Sentenced to 5 Months in Jail

[ Price : $8.95]

A Massachusetts federal judge sentences the former New England Compounding Center operations director to five months in jail for c...

TruLift Lateral Interbody Fusion Spacer Cleared

[ Price : $8.95]

FDA clears a Life Spine 510(k) for the TruLift Lateral Expandable Spacer System and Lateral Plate System for use in lateral lumbar...

FDA Panel Thumbs Down on Heart Failure Drug

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FDAs Cardiovascular and Renal Drugs Advisory Committee votes 8 to 3 against recommending approval of Cytokinetics omecamtiv mecarb...

Endocrinologic/Metabolic Drugs Panel Renewed

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Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.

United Therapeutics Used Priority Voucher on Tyvaso

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Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics sup...

States Pushing for Canadian Drug Imports: Report

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A Kaiser Health News report says four states have now submitted applications to import some drugs from Canada, with others signali...

FDA Accepts NDA for Eye Dilating Combo Product

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FDA accepts for review an Eyenovia resubmitted NDA for MydCombi ophthalmic spray, a drug-device combination product that comprises...

Cardio/Renal Drugs Panel Renewed for 2 Years

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Federal Register notice: FDA renews for two years the charter of its Cardiovascular and Renal Drugs Advisory Committee.

Info Collection on OTC Drug Labeling

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Federal Register notice: FDA sends to OMB an information collection revision entitled General Drug Labeling Provisions and OTC Mon...

$2.25 mil. RWD Funding Opportunity

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CDER and CBER release a $2.25 million funding opportunity announcement to assess the potential utility of real-world data to gener...