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Senate Bill Introduced to Curb High Drug Prices

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Senators Richard Blumenthal (D-CT), Kamala Harris (D-CA), Jeff Merkley (D-OR), and Amy Klobuchar (D-MN) introduce the Curbing Unre...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Wednesday, January 2, 2019.

FDA Equitable Remedy Authority in Doubt: Attorneys

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Two Hyman, Phelps & McNamara attorneys question whether FDA has authority to seek equitable relief in cases involving violations o...

More Benefit than Risk in Non-Device Software: FDA

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FDA says there is more benefit than risk in non-medical device software digital health products.

FDA Pulls Generic Drug Labeling Safety Update Rule

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FDA commissioner Scott Gottlieb says FDA is withdrawing a proposed rule to allow generic drug companies to independently add new s...

Proposed Rule Redefines Biological Product

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Federal Register proposed rule: FDA proposes to amend its regulation that defines biological product to incorporate changes made b...

Priority Review Voucher Awarded to Novimmune

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Federal Register notice: FDA issues a priority review voucher to Novimmune for its approved rare pediatric disease product applica...

IC-Green Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Akorns ICGreen (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial...

FDA Changes Medical Device Classification Regs

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FDA issues a final rule to update procedures for classifying and reclassifying medical devices to conform to change in the FDA Saf...

Tangible Science Hydra Contact Lens Cleared

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FDA clears a Tangible Science 510(k) for its daily disposable silicone hydrogel contact lens coated with a modified formula of Tan...