Drugs

BIO Suggests Improvements to 3 Covid-19 Guidances

BIO says an FDA Covid-19 emergency guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the Covid-19 Public Health Emergency, provides clarity on inspection activities during the Covid-19 pandemic and is an important step in discussions on modernizing inspectional activities. The association’s 7/14 comment letter says that many of the concepts introduced in the guidance should be retained after the public health emergency ends and “become another set of tools in FDA’s toolbox for inspectional activities, utilizing a risk-based approach.”

The letter says BIO has identified areas where additional clarification or detail would be helpful, particularly as it relates to the final remote interactive evaluation report.

BIO also comments on two other emergency guidances — Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency Questions and Answers and Resiliency Roadmap for FDA Inspectional Oversight.

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