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Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 5/27/2022.

ArjoHuntleigh Polska Recalls Floor Lifts

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ArjoHuntleigh Polska recalls its Sara Plus floor lift following several complaints of smoke or flames coming out of the device.

Guide on Prostate Cancer Drug Development

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Federal Register notice: FDA makes available a final guidance entitled Advanced Prostate Cancer: Developing Gonadotropin-Releasing...

FDA Extends Shelf Life for Lillys Bentelovimab

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FDA extends the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtel...

FDA Approves Medtronic In.Pact 018 Balloon Catheter

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FDA approves Medtronics In.Pact 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, indicated for the in...

HHS Withdraws SUNSET Final Rule

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Federal Register notice: Health and Human Services withdraws a final rule entitled Securing Updated and Necessary Statutory Evalua...

Senate Unveils User Fee Reauthorization Bill With FDA Enhancements

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The Senate Health, Education, Labor and Pensions Committee introduces a bill to reauthorize FDAs user fee programs in addition to ...

FDA Denies ICAN Petition on J&J Covid Vaccine

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FDA denies the Informed Consent Action Networks petition that the agency reconsider its response denying an earlier petition calli...

FDA Approves ManaSport Ultrasound Therapy Device

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FDA approves the ManaMed ManaSport Class 2 ultrasound therapy device for pain relief and soft-tissue injuries.

Fast Track for Pfizer Investigational Combination Drug

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FDA grants fast track designation for Pfizers ervogastat/clesacostat combination drug being developed to treat non-alcoholic steat...