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FDA reclassifies surgical staplers for internal use from Class 1 to Class 2 and delays enforcement of the change for 180 days.[ Price : $8.95]
NeuroMetrix submits a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adul...[ Price : $8.95]
FDA issues a revised draft guidance on drug compounding by hospital and health system pharmacies.[ Price : $8.95]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...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled #266 Use of Real-World Data and Real-World Evidence to Supp...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled #265 Use of Data from Foreign Investigational Studies to Su...[ Price : $8.95]
Cassava Sciences says it is opening its first of two Phase 3 efficacy studies of simufilam for use in patients with mild to modera...[ Price : $8.95]
Fagere Drinker consultants analyze a new FDA draft guidance on how the agency handles benefit/risk assessment for drug and biologi...