Drugs

Alternative Facility Assessment Tools Guidance

FDA has published a guidance, Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications, giving applicants information on how the agency intends to use alternative tools to assess drug manufacturing facilities identified in NDAs, BLAs, ANDAs, or their supplements. The document meets a requirement in the PDUFA 7 and BsUFA 3 commitment letters that FDA issue guidance on using alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Covid-19 pandemic.

FDA says the guidance does not apply to other drug inspection programs, including postapproval inspections, surveillance inspections without preapproval or prelicense components, follow-up and compliance inspections, and bioresearch monitoring inspections.

The guidance includes an Introduction, Background, Risk-Based Use of Alternative Tools, Considerations for Alternative Tools, and The Effects of Using Alternative Tools.

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