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Regeneron Urges New Guidances for Precision Medicine

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Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.

Glenmark Pharma Recalls Potassium Chloride

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Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to disso...

Biden Pressured FDA for Pfizer Covid Vaccine: House Report

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A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration politi...

2nd Complete Response on AbbVie Parkinsons Drug

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FDA sends AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuat...

Guide on Lab-Developed Test Compliance Guide

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Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance ...

Rexulti/Sertraline Combo NDA for PTSD

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FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with s...

Vyvgart Hytrulo OKd for Demyelinating Polyneuropathy

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FDA approves Halozyme Therapeutics Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory de...

Workshop in User Fee Meeting Management

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Federal Register notice: FDA announces a 7/22 public workshop entitled Best Practices for Meeting Management.

Device Consensus Standards Modifications

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Federal Register notice: FDA announces a publication containing modifications it is making to the list of standards FDA recognizes...

Invega Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Janssen Pharmaceuticals Invega (paliperidone) extended-release tablet was not withdra...