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Drug User Fee Reauthorization Meeting

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Federal Register notice: FDA announces a 9/28 virtual public meeting entitled Reauthorization of the Prescription Drug User Fee Ac...

Argyle UVC Insertion Tray Class 1 Recall

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Cardinal Health recalls its Argyle UVC Insertion Tray because it does not include specific instructions for using the safety scalp...

Guide on ANDA Bioequivalence Studies

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Federal Register notice: FDA posts a draft guidance entitled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submi...

Industry Seeks Changes to Cancer Trials PROs Guidance

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In comments to FDA, drug companies and industry organizations urge the agency to develop additional and broader guidance on patien...

Alexion Scraps Ultomiris ALS Trial

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Citing a lack of evidence, AstraZenecas Alexion drug unit discontinues its CHAMPION-ALS Phase 3 clinical trial of Ultomiris (ravul...

Cardinal Health Recalls Saline Syringes

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Cardinal Health recalls three models of its Monoject Saline Flush Prefilled Syringes because their plunger may pull air into the s...

FDA Approves Pfizer-BioNTech Vaccine

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FDA approves the first Covid-19 vaccine Pfizer-BioNTechs vaccine that is now under the trade name Comirnaty.

FDA Outlines New Changes to Drug User Fee Program

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FDA posts its Prescription Drug User Fee Act VII commitment letter that describes enhancements to the program that will take place...

Ortho-Cept Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day...

FDA Cautions on Robot Surgical Devices for Mastectomies

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FDA issues a safety alert reminding patients and health care providers that the safety and effectiveness of robotically-assisted s...