Biologics

Objectionable Conditions at Valley Biosystems

An FDA Bioresearch Monitoring Program 8/26/21-10/8/21 inspection at Valley Biosystems, West Sacramento, CA, found “objectionable conditions” in the firm’s conduct of two nonclinical Good Laboratory Practice studies. An 8/3 Warning Letter says specific violations were:

failing to ensure that each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study has education, training, and experience, or a combination of them, to enable the individual to perform the assigned functions; that each testing facility maintains a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study; and that for each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination of them, shall be identified as the study director;
failing to assure that the protocol, including any changes, is approved and followed; that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified; and that unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur; and corrective action is taken and documented;
failure of the quality assurance unit to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection;
failing to retain all raw data, documentation, protocols, final reports, and specimens generated as a result of a nonclinical laboratory study; and
failing to include in the final report a description of all circumstances that may have affected the quality or integrity of the data for each nonclinical laboratory study.

Valley Biosystems was told to respond with written documentation of additional actions it has taken or will take to correct the violations and prevent their recurrence.

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

Read more

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