Drugs

FDA Warns HealthQuilt on Clinical Trial Issues

An 8/4-8/13/20 FDA bioresearch monitoring program inspection at KDunn and Associates, doing business as HealthQuilt, Houston, TX, found objectionable conditions in the company’s work as the sponsor of a clinical investigation into a Covid-19 investigational drug. A 2/16 Warning Letter says specific objectionable conditions were:

failing to submit an IND for the conduct of clinical investigations with an investigational new drug;
failing to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug;
failing to obtain informed consent following regulatory provisions; and
failing to retain records required to be maintained for two years following the date a marketing application is approved for the drug for the indication for which the drug is being investigated or, if no application is filed or approved for such an indication, until two years after the investigation is discontinued.

HealthQuilt was told to respond with a list of specific steps it has 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