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FDA Reclassifies Surgical Staplers, Staples

[ Price : $8.95]

FDA reclassifies surgical staplers for internal use from Class 1 to Class 2 and delays enforcement of the change for 180 days.

De Novo Sought for Fibromyalgia Neuromodulator

[ Price : $8.95]

NeuroMetrix submits a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adul...

Hospital, Health System Drug Compounding Guidance

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FDA issues a revised draft guidance on drug compounding by hospital and health system pharmacies.

Polarean Imaging Complete Response Letter

[ Price : $8.95]

FDA raises issues to be resolved in a complete response letter to a Polarean Imaging NDA for a drug-combination product to enhance...

Guide on Real-world Data for Animal Drug

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Federal Register notice: FDA makes available a final guidance entitled #266 Use of Real-World Data and Real-World Evidence to Supp...

Guide on Foreign Studies for Animal Drugs

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Federal Register notice: FDA makes available a final guidance entitled #265 Use of Data from Foreign Investigational Studies to Su...

Cassava Sciences Opens Phase 3 Alzheimers Trial

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Cassava Sciences says it is opening its first of two Phase 3 efficacy studies of simufilam for use in patients with mild to modera...

FDA Benefit/Risk Guidance Analyzed

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Fagere Drinker consultants analyze a new FDA draft guidance on how the agency handles benefit/risk assessment for drug and biologi...

Acer NDA for Urea Cycle Disorders

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FDA accepts for review an Acer Therapeutics NDA for Acer-001 sodium phenylbutyrate) for treating patients with urea cycle disorder...

FDA Fetal Pharmacology and Therapeutics Workshop

[ Price : $8.95]

FDA announces a 10/21-10/22 virtual workshop on fetal pharmacology and therapeutics.