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Advocates Urge Congress to Rein In FDA Review Uncertainty

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A rare disease advocacy group tells Congress to increase FDA oversight, warning that inconsistent use of regulatory flexibility an...

Senate Committee Presses Pentagon Over FDA Import Exemptions

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The U.S. Senate Special Committee on Aging raises concerns about FDAs handling of foreign drug manufacturing violations and how th...

Ionis' Olezarsen Priority Review for Severe Hypertriglyceridemia

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FDA accepts for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia.

Fresenius Recalls Ivenix Pumps Over Software Issue

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Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.

FDA OKs Dupixent For Allergic Fungal Rhinosinusitis

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FDA approves a Sanofi and Regeneron Pharmaceuticals BLA supplement for Dupixent (dupilumab) and its use for treating adults and ch...

Alert on Abiomed Heart Pumps

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FDA issues an early alert about a potentially high-risk problem involving certain heart pump components manufactured by Abiomed, w...

FDA Division of Applied Regulatory Science Releases Annual Report

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CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advance...

Rep. Gottheimer Introduces 5 Bipartisan Rare Disease Bills

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Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.

CDER Plans 81 New, Revised Guidances in 2026

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FDA releases a list of 81 new and revised guidances in 12 categories that CDER plans to issue this calendar year.

5 CGMP Issues Cited in Ross Healthcare Inspection

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FDA warns Ross Healthcare, in Lynden, WA, about CGMP violations in its production of finished drugs.