Drugs

HealthPartners Neuroscience Center BIMO Issues

FDA says a 3/17-3/21/2025 Bioresearch Monitoring Program inspection at HealthPartners Neuroscience Center Research and Innovation in St. Paul, MN, determined that the facility did not adhere to the applicable statutory requirements and applicable regulations governing the conduct of nonclinical laboratory studies. A 5/19 Warning Letter specifically emphasizes:

failure of the testing facility management to assure that tests for mixtures of articles with carriers were conducted by appropriate analytical methods to determine the uniformity of the mixture and the concentration of the test or control article in the mixture;
failure of the quality assurance unit to review the final study report to assure that the reported results accurately reflect the raw data of the nonclinical laboratory study;
failure of the testing facility management to assure the availability of equipment as scheduled and that the equipment used in the generation, measurement, or assessment of data shall be of appropriate design and adequate capacity to function according to the study protocol; and
failure of the testing facility to establish standard operating procedures in writing, setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of the studies.

“As evidenced by FDA’s inspection findings,” the letter says, “the deficiencies found in the oversight and conduct of the testing facility management and quality assurance unit at your testing facility demonstrate a failure to comply with FDA good laboratory practice regulations governing the conduct of nonclinical laboratory studies. As a result, FDA is concerned about the validity and integrity of the nonclinical data generated by your testing facility.”

HealthPartners was told to respond with a list of specific actions it has taken to prevent such issues 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