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Democrat Lawmakers Seek Probe of Shuren Conflicts

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Two House Democrat lawmakers ask the HHS Office of Inspector General to investigate potential conflict-of-interest appearances rai...

FDA, CBP Seize Counterfeit Weight Loss Drugs

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Media reports indicate that FDA and Customs and Border Protection intercepted $270,000 worth of counterfeit and unapproved weight ...

Piur Device Converting 2D Scans to 3D Cleared

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FDA clears a Piur Imaging 510(k) for the Piur tUS Infinity that transforms existing 2D ultrasound devices into advanced 3D imaging...

Lilly Sues FDA Over Retatrutide Designation

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Lilly asks an Indiana federal court to overturn an FDA determination that the companys retatrutide is a drug rather than a biologi...

Regulatory Review Period for Ojjaara

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Ojjaara (m...

Treat all Biologics the Same: Stakeholders

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Two stakeholders say it is important that FDA state that principles in a question-and-answer guidance on pre-approval manufacturin...

House Passes Pediatric/Rare Disease Bill

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The U.S. House of Representatives passes the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rar...

Eisai Facility FDA-483 Out

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FDA releases the form FDA-483 issued following a 2023 inspection at an Eisai drug manufacturing facility in Gifu, Japan.

Arcutis Bio Files sNDA for Zoryve Expanded Use

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FDA accepts for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3% for treating adults and adol...

5 Observations on Hugel FDA-483

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FDA releases the form FDA-483 with five observations from a 2023 inspection at the Hugel drug substance and product manufacturing ...