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Latest From Cardinal Health, Inc.

Humanigen Aims For New EUA Request After FDA Turns Down Lenzilumab

The company plans to make a new EUA request prior to filing a BLA, but does not yet have a specific timeline. Meanwhile, it has been preparing for the drug’s distribution as a COVID-19 treatment.

Coronavirus COVID-19 Regulation

QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg

Predictions made by Kim Trautman, lead author of the US FDA’s Quality System Regulation, and four other top medtech experts regarding the agency’s upcoming harmonized QSR topped our list of most-read Medtech Insight articles in August.

United States Policy

Cardinal Health: Recall Of 267 Million Monoject Syringes May ‘Contribute To Market Disruption’

The prefilled saline syringes were recalled because they could “reintroduce air into the syringe after the air has been expelled,” the manufacturer explains. The US FDA on 23 August affixed its highest risk classification, class I, to the recall. 

Recalls Safety

2 Deaths Linked To Missing IFU For Cardinal Health Scalpel Used For Newborns

The Safety Scalpel N11 is a component of Cardinal Health’s Argyle UVC Insertion Tray, which was recalled because it didn’t include the scalpel’s instructions for use. The recall has been labeled high-risk class I by the US FDA.

Recalls Safety
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Company Information

  • Industry
  • Contract Research, Toxicology Testing-CRO
  • Distributors
  • Medical Devices
  • Services
  • Services
    • Home Infusion
    • Hospitals, Nursing Homes, Institutions
    • Pharmacy Services, PBMs
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
  • Other Names / Subsidiaries
    • AccessClosure
    • Allegiance Healthcare Corporation
    • Cordis Corporation
    • Innovative Therapies, naviHealth
    • OutcomesMTM
    • The Harvard Drug Group
    • VIASYS Healthcare