Infectious Disease

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FDA cites safety issues, reclassifies C. difficile toxin gene amplification assays

September 1, 2015

The FDA has issued a final order and a special controls guideline to classify toxin gene amplification assays for the detection of Clostridium difficile as class II (special controls) devices “to provide a reasonable assurance of safety and effectiveness.”

The special controls guideline “identifies measures that FDA considers as mitigations to the risks to health associated with these devices.” Companies that submit a 510(k) premarket notification for a C. difficile toxin gene amplification assay will now have to comply with these mitigation measures, which include performing a risk analysis before submission, or demonstrate “at least equivalent assurance of safety and effectiveness” using alternative measures.

In the Journals

Seasonality in China linked to varicella, herpes zoster incidence

September 1, 2015
An increase in ambient temperature was associated with a decrease in outpatient visits for varicella and an increase in outpatient visits for herpes zoster, according to…
In the Journals

Active surveillance significantly reduces SSI rates after neurosurgery

September 1, 2015
The postoperative period for neurosurgery patients is associated with risk factors for surgical site infection that may go unnoticed, but active surveillance during this…

Pfizer continues study of Staphylococcus aureus vaccine for elective spinal fusion surgery

September 1, 2015
Pfizer Inc. announced the enrollment of the first patient in a Phase 2b clinical trial of its investigational Staphylococcus aureus multi-antigen vaccine in adults…

Daktari collaborates with Merck for rapid HCV screening test

September 1, 2015
Daktari Diagnostics announced a new collaboration with Merck over the development of its rapid hepatitis C virus infection screening test, according to a press release…
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CME
Infectious Disease Case Consults

The Patient with Protozoan Illness

No commercial support for this activity.

This CME activity will focus on the diagnosis and management of patients with protozoan illness.
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At Issue Video
VIDEO: Cure is ‘next frontier’ of HIV

VIDEO: Cure is ‘next frontier’ of HIV

July 1, 2015
Timothy Brown – the Berlin patient – has led researchers to the next frontier of HIV research, according to…
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CME
Infectious Disease Case Consults

The Patient with Acute-Bacterial Skin and Skin-Structure Infections

No commercial support for this activity.

This CME activity will focus on the diagnosis and management of patients with acute-bacterial skin and skin-structure…
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