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FDA Tags Data Integrity, Inventory Lapses in AGC Biologics 483

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FDA cites AGC Biologics for deficiencies in laboratory data controls and inventory management at its Bothell, WA, drug substance m...

Biofrontera sNDA Seeks Expanded Ameluz Use

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FDA accepts for review a Biofrontera supplemental NDA seeking to expand the label of its photodynamic therapy drug Ameluz (aminole...

Draft Guide on Medical Gases

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FDA posts a draft guidance entitled Certification Process for Designated Medical Gases.

FDA Hits Tremfya TV Ad as False or Misleading

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The CDER Office of Prescription Drug Promotion cautions Janssen Biotech about a direct-to-consumer TV ad for Tremfya that misleadi...

CBER Head Overruled Staff on Moderna Flu Vaccine Filing

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CBER director Vinay Prasad overrules the Centers career reviewers in deciding to issue Moderna a refusal-to-file letter for its BL...

FDA Not Serious About Mifepristone Review: GOP Senators

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Politico says some GOP senators expressed frustration with FDA over a lack of apparent progress on its supposed safety review of t...

Issues with AI-Enhanced Surgical Devices Cited

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A detailed Reuters report looks at instances of surgical adverse events that may be related to artificial technology-enhanced medi...

FDA OKs Novocures Optune Pax for Advanced Pancreatic Cancer

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FDA approves Novocures Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced panc...

FDA Hits Sobis Vonjo TV Ad as Misleading

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FDA sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (...

Repeat CGMP Violations at Signature Formulations

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FDA warns Phoenix, AZ-based Signature Formulations about repeat CGMP violations in its manufacturing of finished drugs as a contra...