Drugs

Clinical Investigator Violations Cited

A 5/29-6/8 FDA Bioresearch Monitoring Program inspection determined that Ignatius Godoy, Paramount, CA, violated regulations governing the proper conduct of clinical studies involving investigational new drugs in his role as clinical investigator in a study of a quadrivalent inactivated influenza virus vaccine in a pediatric population. A 10/1 Warning Letter says the specific violations were:

failing to obtain the legally effective informed consent of the subjects’ legally authorized representative before involving them in research;
failing to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and the applicable regulations, and to protect the rights, safety, and welfare of subjects under the investigator’s care; and
failing to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug.

The letter says Godoy’s responses to the inspection findings appear to be adequate but lack documentation. He was told to provide written documentation of additional actions that have been taken or will be taken to correct the violations and prevent their recurrence.

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