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Federal Register notice: FDA makes available a draft guidance entitled Self-Monitoring Blood Glucose Test Systems for Over-the-Cou...[ Price : $8.95]
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FDA approves a Catalyst Pharmaceuticals NDA for Firdapse (amifampridine) 10 mg tablets for treating adults with Lambert-Eaton Myas...[ Price : $8.95]
FDA issues two draft guidances with studies and information it recommends be included in 510(k) submissions for blood glucose moni...[ Price : $8.95]
Federal Register notice: FDA issues 22 new and 41 revised ANDA product-specific guidances.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Imp...[ Price : $8.95]
Federal Register notice: FDA announces a 1/17/2019 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Sano...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory ...