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Bill Could End Animal Testing Mandates

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Sens. Paul and Booker introduce legislation to end FDA mandates for animal testing when reliable alternate methods are available.

Immunicom Hires Former FDAer Shenouda

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Immunicom appoints former FDAer Christian Shenouda as vice president of regulatory affairs.

Hold on Allogene CAR T Trial Over Chromosomal Abnormality

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FDA places a clinical hold on Allogene Therapeutics clinical trials involving Allo-501A CAR T cells after a report of a chromosom...

Pfizer Seeks Covid Vaccine EUA for Children 5-12

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Pfizer and BioNTech say they have formally submitted an emergency use authorization request for their mRNA Covid-19 vaccine and it...

Hospital, Health System Drug Compounding Guidance

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FDA issues a revised draft guidance on drug compounding by hospital and health system pharmacies.

Polarean Imaging Complete Response Letter

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FDA raises issues to be resolved in a complete response letter to a Polarean Imaging NDA for a drug-combination product to enhance...

Guide on Real-world Data for Animal Drug

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Federal Register notice: FDA makes available a final guidance entitled #266 Use of Real-World Data and Real-World Evidence to Supp...

Guide on Foreign Studies for Animal Drugs

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Federal Register notice: FDA makes available a final guidance entitled #265 Use of Data from Foreign Investigational Studies to Su...

Cassava Sciences Opens Phase 3 Alzheimers Trial

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Cassava Sciences says it is opening its first of two Phase 3 efficacy studies of simufilam for use in patients with mild to modera...

FDA Benefit/Risk Guidance Analyzed

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Fagere Drinker consultants analyze a new FDA draft guidance on how the agency handles benefit/risk assessment for drug and biologi...