Biologics

Catalent Hit With 12-item 483 on Moderna Vaccine

FDA has issued contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firm’s Bloomington, IN facility that performs fill operations on Moderna’s Covid-19 Bivalent booster vaccine.

The inspection concluded 9/2 and it is intended to add Catalent to Moderna’s emergency use authorization to increase distribution of the booster, according to a 9/20 FDA memo discussing its evaluation. Due to concerns about potential supply limitations, Moderna requested that, in the interim, FDA review and authorize 10 certain batches of the final product produced at the Catalent facility. After reviewing the request, the agency said Moderna “provided sufficient data and information for FDA to determine that these batches are suitable for use and that their known and potential benefits outweigh their known and potential risks for the use… FDA does not intend to determine whether to add Catalent as an authorized manufacturing facility for the Moderna Covid-19 Vaccine, Bivalent until the agency’s evaluation of the inspection is complete.”

According to the inspection report, Catalent was cited for failing to investigate unexplained discrepancies, and to include findings and follow-up actions in its written complaint investigations. Additionally, the inspection found that the firm lacks control procedures to monitor output and validate the performance of those manufacturing processes that may be responsible for variability, among other violations.

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