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FDA Warns Makers of Supplements with Cesium Chloride

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FDA warns five dietary supplement manufacturers that they are producing products containing cesium chloride without meeting agency...

FDA Represents Science in Action: Hahn

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FDA commissioner Stephen Hahn promises that all Covid-19 decisions in the future will be based on science and data, and not politi...

Biohaven sNDA for Migraine Prevention Drug

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FDA accepts for review a Biohaven Pharmaceutical Holding supplemental NDA for Nurtec ODT (rimegepant) for preventing migraines.

Clinical Hold on Voyager Therapeutics Gene Therapy

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FDA places a clinical hold on a Voyager Therapeutics planned clinical trial for VY-HTT01 for treating Huntingtons disease.

Require Better De Novo Evidence: Researchers

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Researchers say FDA could ensure better evidence in medical device de novo clearances by requiring that devices meet prespecified ...

FDA Clears ImmersiveTouch Surgical Planner

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FDA clears an ImmersiveTouch 510(k) for its ImmersiveView Surgical Plan digital surgery platform.

Dont Expect Much from New Drug Import Programs: Analysis

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Hogan Lovells attorneys say that new FDA and CMS drug importation provisions are unlikely to lead to any increase in drugs importe...

NIH Pauses Lilly Covid Antibody Trial

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The NIH puts a safety hold on the Abbott ACTIV-3 trial of a Covid-19 antibody therapy.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Haloderm and Oneness Labs.

miR Scientific Gain Breakthrough for Prostate Assay

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FDA grants miR Scientific a Breakthrough Device Designation for its miR Sentinel PCC4 Assay for prostate cancer analysis.