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CorneaGen Recalls 1 Lot of Scleral Patch Grafts

[ Price : $8.95]

FDA provides information on a CorneaGen recall of one lot of scleral patch grafts.

NeuroMetrix De Novo Authorization for Fibromyalgia

[ Price : $8.95]

FDA grants NeuroMetrix a de novo authorization to market its Quell neuromodulation device as an aid for reducing fibromyalgia symp...

Warning on Genetic Prenatal Screening Tests

[ Price : $8.95]

FDA issues a warning about the risks of false results with genetic non-invasive prenatal screening tests.

Bill Would Whittle Down Biologic Exclusivity

[ Price : $8.95]

Congresswoman Jan Schakowsky (D-IL) and congressman Bruce Westerman (R-AR) reintroduce the bipartisan Price Relief, Innovation, an...

Partial Clinical Hold on Leukemia Therapy

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FDA issues a partial clinical hold on a Foghorn Therapeutics Phase 1 dose escalation study of FHD-286 in relapsed or refractory ac...

FDA Withdraws 21 No-longer-marketed ANDAs

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Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the produ...

More Product-specific Bioequivalence Guides

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances.

Guide on New Dietary Ingredient Notifications

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Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding Certain New Dietary Ingredients and Dietar...

Device Cybersecurity Clarifications in FDA Webinar

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FDA announces a 6/14 Webinar to share information and answer questions about its recent draft guidance entitled Cybersecurity in M...

FDA Approves Dupixent for Eosinophilic Esophagitis

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FDA approves Regenerons Dupixent (dupilumab) for treating eosinophilic esophagitis in adults and pediatric patients 12 years and o...