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Dog Heartworm Prevention Drug Guidance

[ Price : $8.95]

FDA publishes a guidance with additional details on earlier guidances on evaluating the effectiveness of drugs indicated to treat ...

6 Observations in Cipla FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at a Goa, India, Cipla drug manufacturing facility.

FDA Opening Office in Rwanda

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FDA associate commissioner for global policy and strategy Mark Abdoo says the agency will support the African Medicines Agency thr...

FDA Modifies CAR T Cell REMS

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FDA modifies the REMS for CAR T cell products to ease the burden on hospitals and their clinics.

Draft Guide on Diversity Action Plans

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Federal Register notice: FDA makes available a draft guidance entitled Diversity Action Plans to Improve Enrollment of Participant...

Guide on Priority Zoonotic Drug Designations

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Federal Register notice: FDA makes available a final guidance entitled Priority Zoonotic Animal Drug Designation and Review Proces...

Complete Response on BLA for Lung Cancer Combo

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FDA sends Daiichi Sankyo and Merck a complete response letter on their BLA for patritumab deruxtecan (HER3-DXd) for treating certa...

Schakowsky Introduces Drug Import Bill

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Rep. Jan Schakowsky and seven others introduce legislation to authorize the importation of prescription drugs from Canada, the UK,...

START Pilot Helps Rare Disease Treatments: Cavazzoni

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CDER and CBER announce seven participants in the START pilot program to speed development of treatments for rare diseases.

Torrent Pharmaceuticals FDA-483

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FDA releases the form FDA-483 with five observations from an inspection at the Torrent Pharmaceuticals facility in Indrad, Gujarat...