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FDA Approves Catalyst Firdapse for LEMS

[ Price : $8.95]

FDA approves a Catalyst Pharmaceuticals NDA for Firdapse (amifampridine) 10 mg tablets for treating adults with Lambert-Eaton Myas...

2 New Blood Glucose Monitor Guidances

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FDA issues two draft guidances with studies and information it recommends be included in 510(k) submissions for blood glucose moni...

FDA Updates ANDA Product-specific Guides

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Federal Register notice: FDA issues 22 new and 41 revised ANDA product-specific guidances.

Draft Guide on Dual 510(k) and CLIA Waiver

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Federal Register notice: FDA makes available a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Imp...

Panel to Review Sanofi Diabetes Drug

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Federal Register notice: FDA announces a 1/17/2019 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Sano...

Draft Guide on CLIA Recommendations

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory ...

Stroke Risk Safety Alert on Genzymes Lemtrada/Campath

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FDA issues a drug safety alert to warn about rare but serious cases of stroke and tears in the lining of arteries in the head and ...

Draft Guide on CLIA Recommendations

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory ...

Caregivers Missing Safety Signals on Celgenes Idhifa

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FDA warns that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being identified in pa...

FDA Inspection Agreements with 20 EMA Members

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The European Medicines Agency says FDA has confirmed the capability of five more member states to conduct drug inspections.