Drugs

Trial Enrolled Ineligible Subjects: FDA

Clinical investigations overseen by Gregory Tracey, Hoboken, NJ, did not follow the investigational plan and enrolled ineligible subjects, according to a 12/16/15 Warning Letter from FDA. The letter was a result of a 3/25-4/15/15 inspection as part of the agency’s Bioresearch Monitoring Program.

The letter says that the investigational plan for the unidentified protocol in question required that Tracey verify that study subjects meet all eligibility criteria and in particular that subjects not be included with a positive serum pregnancy test at screening or check-in. “You failed to adhere to these requirements,” it declares. “We emphasize our concern that you failed to fully evaluate the eligibility criteria for the study that were specifically designed to minimize foreseeable harm to enrolled subjects and to maintain the interpretability of collected data. The enrollment of ineligible subjects raises significant concerns about the adequacy of the protection of study subjects enrolled at your site, and also raises concerns about the integrity of the data collected at your site.”

Tracey was told to respond with a list of actions taken to prevent similar violations in the future.

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