FDA Policy/General

Research Violations at Texas Sleep Center

An 11/7-11/10/16 FDA inspection at Pulmonary and Sleep Center of the Valley, McAllen, TX, conducted as part of the Bioresearch Monitoring Program, determined that the center did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects. A just-released 4/20 Warning Letter says the center failed to ensure that an investigation was conducted according to the investigational plan.

“Your lack of supervision and oversight of the clinical study raises significant concerns about the adequacy of your protection of the study subjects enrolled at your site … and raises concerns about the integrity of data generated at your site,” the letter says. “Enrollment of subjects who do not meet eligibility criteria and failure to perform protocol-require procedures … jeopardize subject safety and welfare, and raise concerns about the validity of the data collected at your site. Of particular concern is the fact that three of the four subjects enrolled on the … study at your site were ineligible for enrollment into the protocol.”

Center director Adolfo Kaplan 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