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Mesoblast Sent Another Complete Response Letter

[ Price : $8.95]

FDA sends Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute...

Biosense Webster New Label on Cardiac Ablators

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FDA approves new labeling to permit several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy ...

FDA Floats Food-Animal Antibiotic Use Group

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FDA solicits comments on a report outlining a structure for a public/private partnership to establish and operate a repository of ...

FDA OKs Merck Ebola Vaccine for Children

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FDA approves an expanded indication for Mercks Ebola vaccine Ervebo (Ebola Zaire vaccine, live) to include its use in individuals ...

Imeka Brain White Matter Imaging Cleared

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FDA clears an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to ge...

Meeting on Study Disruptions During Emergencies

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Federal Register notice: FDA announces a 10/18-19 public meeting entitled Mitigating Clinical Study Disruptions During Disasters a...

Guide on User Fee Waivers for HIV Drugs

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Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Sin...

Guide on Antiretrovirals for HIV1 Under PEPFAR

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Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously...

DSCSA Can Lead to Drug Shortages: Reps

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A bipartisan group of 28 House members asks FDA about the potential for drug shortages if supply chain members cant meet the 11/27...

DSCSA Waiver, Exception, Exemption Guidance

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FDA publishes a guidance explaining the process for requesting a waiver, exception, or exemption from provisions of the Drug Suppl...