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FDA Cites QOL Medical for Misleading Promotion of Sucraid

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FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) ...

FDA Warns Brazilian Drug Maker Over Records Request

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FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed ...

HealthPartners Neuroscience Center BIMO Issues

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FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations ...

3-Year New Clinical Investigation Exclusivity Guidance Explained

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Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.

Senate Committee Postpones FDA Funding Bill Consideration

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Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republ...

Repeat Medline CGMP Violations Cited

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FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.

CGMP Violations at Laboratorios Jaloma

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FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.

Manufacturer Economic Info Communications Q&A Guidance

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FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.

ICH Finalizes Guide on Model-Informed Drug Development

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FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computationa...

Guide on Using Prior Knowledge for Genome Editing Gene Therapies

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FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufact...