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Prospective AI Versioning Standard Needed: Post

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A Clinical Trial Vanguard online post makes the case for further FDA guidance so drug trial sponsors can successfully incorporate ...

Purdue Sentencing Sets $5.3 Billion in Criminal Penalties

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A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic...

Reviewers Brief ODAC on Camizestrant Concerns

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FDA medical reviewers ask the Oncologic Drugs Advisory Committee to consider their concerns about the benefit-risk assessment of A...

Celgene Cell Therapy Facility Hit with Form 483

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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

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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...