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14 Submissions with RWE in FY 2023: FDA

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FDA publishes a table with information on 14 drug submissions in FY 2023 that contained real-world evidence.

Sani-Care Salon Products CGMP Violations

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FDA warns Cartersville, GA-based Sani-Care Salon Products about CGMP violations in its work as a contract manufacturer of finished...

HCTP Violations at Indiana Lions Eye Bank

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FDA warns the Carmel, IN-based Indiana Lions Eye Bank about deviations from the regulations for human cells, tissues, and cellular...

NDRP Modernization Successes Lead to Permanent Initiative

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CDER Office of New Drugs Special Program Staff associate director Yoni Tyberg discusses the New Drug Regulatory Program modernizat...

AdvaMed Concerned with Device Remanufacturing Guide

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Advanced Medical Technology Association says there are inconsistencies and ongoing concerns with FDAs guidance on remanufacturing/...

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 ...