Drugs

FDA Cites 2 Minn. Clinical Investigators

FDA has just released the FDA-483s issued following 2019 inspections of two trial investigators at the Hennepin County Medical Center Department of Emergency Medicine in Minneapolis, MN.

A 4/10-4/26/19 investigation of Jon Cole, clinical investigator, found these observations:

failing to submit an IND to FDA before conducting a clinical investigation with an investigational new drug;
failing to obtain legally effective informed consent from a subject of the subject’s legally authorized representative in a situation that did not meet criteria for an exception;
failing to conduct an investigation in accordance with the investigational plan;
failing to ensure proper monitoring of the study;
failing to maintain adequate investigational drug disposition records with respect to dates, quantity, and use by subject; and
failing to have all changes in research activity approved by an institutional review board before implementation.

A 4/9-4/23/19 investigation of Lauren Klein, sponsor-investigator, found these observations:

failing to submit an IND to FDA before conducting a clinical investigation with an investigational new drug;
failing to obtain legally effective informed consent from a subject or the subject’s legally authorized representative in a situation that did not meet criteria for an exception;
failing to have all changes in research activity approved by an institutional review board before implementation;
failing to conduct an investigation in accordance with the investigational plan;
failing to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation and informed consent; and
failing to ensure proper monitoring of the study.

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