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Follow FDA Online Misinformation Guidance: Attorneys

[ Price : $8.95]

Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformat...

DeepWell Digital Software Cleared for Stress Relief

[ Price : $8.95]

FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatme...

Whole Exome Sequencing Devices are Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies whole exome sequencing devices into Class 2 (special controls).

Aisa Pharma Orphan Status for Cilnidipine

[ Price : $8.95]

Aisa Pharma wins an FDA orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating system...

CGMP Violations at Zydus Lifesciences Facility

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FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.

Multiple Optikem International Violations Cited

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FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthal...

Changes Sought in FDA Misinformation Guidance

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Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation abou...

FDA Clears Sonic Incytes Velacur Device

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FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.

Priority Voucher Used on Incytes Opzelura

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Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority rev...

FDA Mulls More Post-Inspection Feedback: Cavazzoni

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CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to lea...