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Takeda Gains Breakthrough for Pevonedistat

[ Price : $8.95]

FDA grants Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug pevonedistat for treating patient...

Draft Guide on Pregnancy, Lactation Drug Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Pregnancy, Lactation, and Reproductive Potential: Labeling ...

FDA Reiterates Deep Brain Stimulator Risk

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FDA reminds patients, caregivers, and healthcare providers about the risks associated with deep brain stimulation devices when use...

Next PPE Webinar Set for August 4

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FDA says its next Webinar on respirators and other personal protective equipment will be on 8/4.

FDA Approves Roche Ventana Diagnostic Test

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FDA approves the Roche Ventana diagnostic assay to detect the HER2 biomarker in breast cancer and help determine candidates for th...

Info Collection on OTC Drugs as GRASE

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Federal Register notice: FDA seeks comments on an information collection extension for additional criteria and procedures for clas...

Vaccine EUA Would Follow Efficacy: Marks

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CBER director Peter Marks tells an online health summit that a Covid vaccine EUA could be approved within weeks after a vaccine me...

FDA Draft Guide on Endotoxin Limits

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Federal Register notice: FDA makes available a draft guidance entitled Setting Endotoxin Limits During Development of Investigatio...

Rule on Animal Drug e-Submission Safety Reports

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Federal Register notice: FDA issues a final rule to require electronic submission of certain postmarketing safety reports for appr...

Guide on Multiple Function Device Products

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Federal Register notice: FDA makes available a final guidance on Multiple Function Device Products: Policy and Considerations; Gui...