Drugs

Avila Herbals Did Not Follow Trial Rules: FDA

A 7/12-7/26/21 FDA Bioresearch Monitoring Program inspection at Avila Herbals, Christiansburg, VA, determined that the owner/clinical investigator did not follow applicable legal requirements governing the conduct of clinical investigations and the protection of human subjects. A 2/4 Warning Letter cites these issues:

failing to submit an IND for the conduct of a clinical investigation with an investigational new drug;
failing to assure that an institutional review board was responsible for the initial and continuing review and approval of the proposed clinical study;
failing to obtain informed consent; and
failing to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.

FDA says Avila’s responses to the inspection observations cannot be evaluated because Avila did not provide sufficient information and documentation. Avila was told to respond with a list of actions 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