Drugs

No Informed Consent at Trial Site: FDA

FDA says a Bioresearch Monitoring Program inspection at a clinical trial site maintained by Dr. Americo Padilla/Miami Dade Medical Research Institute determined that the site did not follow laws and regulations governing the conduct of clinical investigations and the protection of human subjects. A 1/17 Warning Letter says the site failed to obtain informed consent from two subjects’ parents or guardians as specified in regulations.

The letter acknowledges Padilla’s response and commitment to implement corrective and preventive actions and says the agency can’t undertake an informed evaluation of the response’s adequacy because Padilla did not provide sufficient details on the corrections.

“We are particularly concerned about the severity of the violations and their potential effect on subjects’ rights, since pediatric subjects are considered a vulnerable population,” FDA says.

Padilla was told to respond with a list of specific 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