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Drug Delivery Device Guidance

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FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery p...

Philips Updates BiPAP Ventilator Use Instructions

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FDA says Philips Respironics has updated use instructions for three BiPAP ventilators in a Class 1 recall.

SCOTUS Chevron Decision Harms the Public: Coalition

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The Coalition for Sensible Safeguards calls on Congress to enact Chevron deference into law following a Supreme Court decision gut...

Abbott Recalls HeartMate System Monitor

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Abbott Medical recalls (Class 1) its HeartMate System Monitor due to atypical behavior of the System Monitor screen.

Dog Heartworm Prevention Drug Guidance

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Federal Register notice: FDA makes available a draft guidance entitled Diversity Action Plans to Improve Enrollment of Participant...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