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Human Drugs

Nevada Man Pleads Guilty to Importing and Selling Misbranded Drugs

A Nevada businessman enters guilty plea to importing and distributing misbranded prescription erectile dysfunction drugs from India.

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Human Drugs

Study Finds Compounded GLP-1 Market Remains Strong Despite FDA Crackdown

A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the FDA's resumption of e...

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FDA General

FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says

In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are increasingly extending ...

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FDA General

Opinion Piece Praises Diamantas' Vision for FDA Modernization

A 7/20 opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing FDA by emphasizing innovation,...

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Medical Devices

FDA Issues Early Alert on Baxter IV Administration Sets

FDA issues an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solution sets that could ...

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Human Drugs

Fujifilm Diosynth Cited Over NC Plants Microbial Contamination Controls

FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Research Triangle Park, N...

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Human Drugs

Camurus NDA Resubmission for Acromegaly Therapy Accepted by FDA

FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly.

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Medical Devices

Class I Recall of Bolton Medicals Relay Pro Thoracic Stent Graft System

Bolton Medical recalls its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death.

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Human Drugs

FDA Cites Charles River Endosafe Lab Over Quality System Deficiencies

FDA issues a Form-483 to Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies...

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Marketing

Friendly Accelerated Approval Disclosures Improve Drug Understanding: Study

A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated approvals when disc...