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Info Collection on FDA Quantitative Testing

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Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Tes...

CDER Used AI/ML in Kineret EUA

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CDER explains how it used artificial intelligence/machine learning (AI/ML) to help identify the patient population most likely to ...

Zymedi Gets Orphan Status for ZMA001

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FDA grants Zymedi an orphan drug designation for ZMA001, a monoclonal antibody in development for pulmonary arterial hypertension.

Alert on Megadyne Patient Return Electrodes

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FDA and Health Canada issue a notice alerting healthcare providers and facilities about the safe use of Megadyne Medical Products ...

Ways to Improve OS Data Collection, Analysis

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Researchers from FDA and other entities recommend ways to improve the collection and analysis of overall survival (OS) data in can...

Stakeholder Comments on Cell, Gene Guidance

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Three stakeholders recommend changes to an FDA draft guidance on human- and animal-derived materials in cell and gene therapeutic ...

FDA Publishes ICH Bioequivalence Guidance

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FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage...

FDA Clears Life Spine Sacroiliac Fixation Device

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FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.

FDA May Allow Novel Carve-Ins: Attorneys

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Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.

Medical Device User Fee Rates

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Federal Register notice: FDA sets the medical device user fee rates for fiscal year 2025.