Drugs

‘Objectionable Conditions’ at Avanti Study Site: FDA

A 7/19-8/5/21 FDA inspection under the Bioresearch Monitoring Program at the clinical site operated by Dr. Maggie Jeffries/Avanti Anesthesiology in Houston, TX, found that the site did not adhere to the applicable statutory requirements and regulations governing the conduct of clinical investigations and the protection of human subjects. A 3/3 Warning Letter stresses that Jeffries failed to submit an IND for the conduct of a clinical investigation with an investigational new drug.

In the letter, FDA rejects Jeffries’ contention that an IND was not needed for the investigation in question. “As noted above,” it says, “the investigation conducted under protocol ANES001 was a clinical investigation as defined by [regulations] and is subject to the requirement that an IND must be in effect before initiation unless all the exemption criteria … are met. Because the administration of the investigational drugs (diazepam, tramadol, ondansetron, and MKO Melt) in this clinical investigation significantly increased the risks and/or decreased the acceptability of the risks associated with the use of these drug products, and because you failed to conduct the investigation in compliance with the informed consent requirements … the exemption criteria … were not met and … you were required to submit and to have in effect an IND before initiating this clinical investigation.”

FDA says Jeffries’ written response did not provide any assurance of corrective actions or a corrective action plan explaining how she would comply with IND regulations moving forward. As a result, it says, her response is inadequate and the agency is unable to determine whether she will comply with IND regulations in the future.

Jeffries was told to respond with a list of specific steps she 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