Drugs

FDA Releases Novartis Untitled Letter on GMPs

FDA has just released an 8/8 untitled letter issued following an 11/28-12/9/2022 inspection at the Novartis manufacturing facility in Morris Plains, NJ. The letter says agency investigators documented significant deviations from current good manufacturing practice (CGMP) requirements in the manufacturing of the company’s Kymnah (tisageniecleucel) biologic product. The letter says deviations listed on an FDA-483 were:

failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closure, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
failing to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they are purported or represented to possess.

The letter told Novartis to respond with a list of specific steps it has taken to correct the noted deviations and prevent their recurrence, with any documentation necessary to show that the issues have been addressed.

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