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14 articles found
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FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for AnimalsToday, the U.S Food and Drug Administration issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues, and cell- and tissue-based prod... -
Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of OperationsToday, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemi...
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FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities th...
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FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in DogsToday, the U.S. Food and Drug Administration conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system. Laverdia-CA...