Drugs

Contract Awarded to CRO to Validate Patient-reported Outcomes

FDA has awarded contract research organization ICON a contract to validate three patient reported outcomes (PRO) instruments that will measure clinical endpoints in antibacterial drug trials. The conditions in which the endpoints will be validated are acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia and hospital-acquired bacterial pneumonia.

Under the contract, ICON’s Clinical Outcomes Assessment group, in collaboration with the Biomarkers Consortium of the Foundation for the National Institutes of Health, will create an electronic platform to validate the key PROs, allowing investigators to assess symptoms at various time points over the course of the infection and measure the effects of antibacterial drugs. The PROs will be implemented on CRF Health’s TrialMax eCOA platform, allowing patients to use the application on a handheld device during the course of the trials, according to ICON. “These PROs will continue to be validated and developed in accordance with the FDA guidance for PRO measures used to support labeling claims and will follow the Drug Development Tool Qualification Program,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome