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Celgene Cell Therapy Facility Hit with Form 483

[ Price : $8.95]

FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including defic...

GSK NDA Accepted for Hepatitis B Drug

[ Price : $8.95]

FDA accepts for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen.

Insulet Class 1 Recall of Insulin Pump Components

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Insulet recalls (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death.

8 Observations on Fujifilm Diosynth FDA-483

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FDA releases the form FDA-483 with eight observations from an inspection at the Fujifilm Diosynth Biotechnologies Texas drug manuf...

CGMP Violations at Lexia LLC

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FDA warns Franklin, TN-based Lexia LLC about CGMP violations in its production of over-the-counter drugs and cosmetic products

Multiple Violations in Foshan Miwei Cosmetics Inspection

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FDA warns Chinas Foshan Miwei Cosmetics Co. about CGMP violations in its production of three misbranded unapproved new over-the-co...

CGMP Issues at Intas Dehradun Unit

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FDA warns Intas Pharmaceuticals Limited about CGMP violations in its production of finished drugs at the manufacturing facility in...

J&J Imaavy sBLA for Rare Anemia Gets Priority Review

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FDA accepts for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for wa...

Tavneos Withdrawal Sought Over Data Manipulation, Safety Risks

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FDA moves to increase pressure on Amgen to withdraw approval of autoimmune disease drug Tavneos (avacopan), concluding that the th...

FDA Evaluating Measures to Modernize Clinical Trials

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FDA seeks to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a b...