Drugs

REMS Logic Model Draft Guidance

FDA has released a draft guidance entitled “REMS Logic Model: A Framework to Link Program Design With Assessment. The document describes FDA’s risk evaluation and mitigation strategy (REMS) logic model, which it describes as a recommended framework to provide applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS.

FDA says it began in 2018 assessing the feasibility and utility of applying commonly used and validated scientific frameworks to REMS assessments, and it concluded that “frameworks provide a logical, structured approach for determining what outcomes should be measured, when the outcomes should be measured, and the process and health impact indicators for facilitating these measurements.” It also identified areas for strengthening and improving REMS assessments, including the following:

Linking program design assumptions with program evaluation metrics to validate the assumptions, allow for modifications, and improve program performance
Improving and increasing outcomes and health impact measures
Identifying measures to assess integration and sustainability of REMS into the healthcare system and clinical practice to help determine whether the REMS requirements can be eliminated
Identifying a primary outcome measure to determine whether the REMS goal is being met

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