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Industry Explains PDUFA 8 Facility Lifecycle Counterproposal

[ Price : $8.95]

A PDUFA 8 negotiating subgroup reviews industrys counterproposal to FDAs facility lifecycle proposal.

Telehealth Firm Undercuts Novo GLP-1 Pill Price: Reuters

[ Price : $8.95]

Reuters reports exclusively that the telehealth firm Hims and Hers Health is selling GLP-1 pills for $100 less per month than the ...

J&Js Cerenovus Recalls Neurovascular Coil Devices

[ Price : $8.95]

Johnson & Johnson MedTech recalls multiple versions of its Cerepak Detachable Coil System, which are used to treat intracranial an...

Software Assurance Guidance Supplement

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FDA publishes a guidance with recommendations on computer software assurance for computers and automated data processing systems u...

FDA Updates Safety Labels for Chemo Drugs

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FDA updates the safety labeling for the widely used chemotherapy drugs capecitabine (Genentechs Xeloda) and fluorouracil (multiple...

QS Violations at Flextronics America

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FDA warns Austin, TX-based Flextronics America about Quality Systems violations in its manufacturing of a continuous glucose meter...

CGMP Violations Found in Cohance Lifesciences Inspection

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FDA warns Indias Cohance Lifesciences about CGMP violations in its production of drugs at one of its manufacturing sites.

Stakeholders Perspective on Nonprescription Drug Access

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Three drug trade associations give FDA their perspectives on increasing access to nonprescription drugs.

New Device Inspection Protocol Analyzed

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Three Hogan Lovells attorneys analyze the new FDA medical device inspection compliance program and caution manufacturers to begin ...

Class I Recall of Abbott FreeStyle Libre 3 Glucose Sensors

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FDA classifies Abbott Diabetes Cares recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring ...