Drugs

FDA Tightening Internal Lab Safety

FDA says it is currently reviewing its internal laboratory safety program to align with ongoing, shifting, and future priorities. As part of the safety program, the agency’s Office of Laboratory Safety (OLS) has also “initiated a collaborative effort to adopt and standardize a laboratory safety audit and inspection process across the agency that will support the existing center-based safety staff and procedures,” an FDA post says.

During the pandemic, FDA labs continue to conduct research on developing new approaches, standards, and methods for evaluating the safety, efficacy, quality, and performance of regulated products. “FDA laboratories have also continued to analyze the quality and safety of product samples collected during mission-critical inspections as well as at ports of entry throughout the Covid-19 pandemic,” the post says. “Moreover, the FDA’s state-of-the-art laboratory complexes perform research supporting development of medical products, such as vaccines to combat potentially pandemic strains of influenza as well as vaccines and therapies for global diseases like HIV, tuberculosis, malaria, and, of course, Covid-19. The laboratory complexes house more than 2,500 researchers and have modern suites to ensure the safe and secure storage and use of biological materials and specimens.”

Additionally, OLS has collaborated with FDA Centers and offices to develop internal laboratory safety guidelines. “These guidelines aim to ensure safe practices in laboratories across the FDA and describe a six-step, layered approach to preventing transmission and exposure to Covid-19 in the laboratory and vivarium spaces,” the agency says. “Also included are other resources, such as tools that enable the agency to determine how much personal protective equipment (PPE) laboratory staff have available to be able to complete their work safely, a return to laboratory operations checklist, and information on PPE and face coverings.”

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