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Allergans Ireland Plant Hit With 483 After Inspection

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FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland fo...

Town Hall on BLA Submissions for Cell and Gene Therapies

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FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy...

PhRMA Urges Changes to FDAs Plausible Mechanism Guidance

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PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and ...

Expanded Access Program for Promising Pancreatic Cancer Drug

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FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certai...

Veppanu Approved for Advanced Breast Cancer

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FDA has approved Arvinas Operations Veppanu (vepdegestrant) for treating certain patients with advanced breast cancer, marking the...

Eugia Pharma Specialties FDA-483 Out

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FDA releases the form FDA-483 with three observations from an inspection at Indias Eugia Pharma Specialties Limited.

Keep GLP-1s Off Bulks List: FDA

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FDA proposes not to include semaglutide, tirzepatide, and liraglutide on the 503 Bulks List of drugs that can be legally compounde...

Nubeqa TV Ad, Video Misleading: FDA

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The CDER Office of Prescription Drug Promotion cautions Bayer that a video and TV ad for its Nubeqa omit important risk informatio...

Using AI in Drug Development

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Five Hogan Lovells attorneys discuss ways in which life sciences companies can use artificial intelligence in drug development and...

House Committee Advances FDA Funding Bill Amid Policy Disputes

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The U.S. House Appropriations Committee votes to approve a spending bill to fund FDA for fiscal year 2027.