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15 Observations in Jubilant HollisterStier FDA-483

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FDA has released the form FDA-483 issued with 15 observations from an inspection at the Jubilant HollisterStier drug manufacturing...

Cardiosense Wearable Cleared as Heart Function Monitor

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FDA clears a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram,...

FDA Makes ISTAND Pilot Permanent

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FDA says the Innovative Science and Technology Approaches for New Drugs pilot is transitioning into a permanent drug development t...

Trump Overruled Makary, RFK, to Fire Prasad: Sources

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Politico reports that despite strong support from FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., Preside...

Senate Amendment Seeks to Block Illicit Drug Imports

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U.S. Senators Ted Budd (R-NC) and Martin Heinrich (D-NM) introduce a bipartisan amendment to FDAs fiscal year 2026 spending bill t...

FDA Orders New Mandatory Opioid Labeling

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FDA orders new mandatory safety labeling changes for all opioid analgesics, a move aimed at curbing long-term misuse of the produc...

MDUFA Small Business Qualification Guide

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FDA publishes a guidance explaining the process it uses to determine and qualify a MDUFA small business.

Vivace Mesothelioma Drug Gets Orphan Status

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FDA grants Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma.

House Dems Hit FDA, HHS Over Vaccines

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Top House Democrats on the Energy and Commerce Committee raise alarm over what they describe as a coordinated effort by the Trump ...

FDA Lays Out Unapproved GLP-1 Drug Concerns

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FDA issues an online statement summarizing all its concerns with unapproved versions of GLP-1 weight loss drugs being marketed to ...