Drugs

CDER OSI Annual Report

The CDER Office of Scientific Investigations (OSI) completed 128 medical product-related clinical inspection summaries (consults) in support of user fee applications received from 24 of the 27 CDER clinical review divisions during Fiscal Year 2023. The OSI annual report says the consults resulted in 418 inspectional observations, 351 with clinical investigators, and 67 with sponsors/contract research organizations. Some 281 of the 418 consults were domestic and 137 were foreign.

The report says the OSI mission is to ensure that products regulated by CDER are safe and effective for the life of the product, through oversight and enforcement activities involving the:

reliability of safety and efficacy data submitted to FDA;
application of human subject protections in clinical trials; and
FDA requirements for Risk Evaluation and Mitigation Strategies, Postmarketing Adverse Drug Experience, and required postmarketing studies.

OSI says it has identified these three areas of strategic focus and their supporting goals: (1) proactively promote compliance through policy development, clear communication, and collaboration with stakeholders; (2) optimize and modernize Bioresearch Monitoring Program operations and pursue effective and risk-based regulatory and enforcement actions; and (3) pursue organizational excellence in workplace culture, human resources, and business processes.

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