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Harmonize Innovative Manufacturing Regulation: PhRMA

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Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufac...

AdvaMed Supports Breakthrough Device Guidance Updates

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AdvaMed says it strongly supports FDA efforts to update a guidance on the breakthrough devices program.

VALID Could Hurt Home Sample Testing: Attorneys

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Two Hyman, Phelps attorneys say the VALID bill contains what appears to be an inadvertent provision that could adversely affect te...

Fresenius Kabi Gains Approval for Humira Biosimilar

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FDA approves a Fresenius Kabi BLA for Idacio (adalimumab-aacf), a biosimilar product referencing AbbVies Humira (adalimumab).

Former NECC Ops Director Sentenced to 5 Months in Jail

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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

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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...

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...