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FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says

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

Opinion Piece Praises Diamantas' Vision for FDA Modernization

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

FDA Issues Early Alert on Baxter IV Administration Sets

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

Fujifilm Diosynth Cited Over NC Plants Microbial Contamination Controls

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FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Resea...

Camurus NDA Resubmission for Acromegaly Therapy Accepted by FDA

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

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

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

FDA Cites Charles River Endosafe Lab Over Quality System Deficiencies

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

Friendly Accelerated Approval Disclosures Improve Drug Understanding: Study

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

Alvotech EF FDA-483 Released

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FDA releases the form FDA-483 with five observations from an inspection at Icelands Alvotech EF.

Court Backs FDA, Medtronic in Stimulator Suits

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MassDevice reports a Minnesota federal judge gave significant victories to Medtronic and FDA in four cases involving the companys ...