Drugs

Inspections Focusing on Management Responsibility: FDA

FDA inspections of drug manufacturing operations are going to be geared to increased scrutiny of management’s responsibility and risk management operations, according to FDA Office of Regulatory Affairs (ORA) Division of Pharmaceutical Quality Operations III program director Jeffrey Meng. He provided an ORA compliance update during an online PharmaLink conference hosted by the Regulatory Affairs Professionals Society (RAPS) and the Association of Food and Drug Officials. A summary of Meng’s comments was posted by RAPS following the conference.

Meng said an outline of the agency’s interest can be found in the recently updated compliance policy guideline (CPG) on GMP surveillance inspections. Meng said the CPGs are “critical” and are the agency’s’ “bread and butter for inspections going forward,” according to the RAPS summary. “We expect formal implementation of risk management programs so that we can have better assurance over the quality system of the product being manufactured,” he said.

In FY 2022, Meng said FDA sent 62 Warning Letters and issued 23 import alerts related to drugs, excluding drug compounding-related actions. “The number of Warning Letters prompted by onsite inspections increased dramatically in FY 2022; 42 (67.7%) of the Warning Letters followed onsite inspections, while 16 (25.8%) resulted from inspecting samples and four (6.5%) were the result of a records request,” he said.

In FY 2021 and mainly because of the pandemic, fewer Warning Letters were the result of an onsite inspections, according to Meng. For example, only 21 (25.3%) Warning Letters followed onsite inspections, and the remainder resulted from alternative tools — 59% were from testing samples, and 13.3% emanated from a records request, while 2.4% were from a refusal of a Section 704 records request.

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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’

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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