Drugs

Guide on Combo Product Risk Analyses

FDA has released a draft guidance entitled “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.” The document provides information on the purpose and content of a use-related risk analysis (URRA) and how this, along with other information, can be used to determine human factors (HF) data needs during product development and to support a marketing application. It applies to drug- and biologic-led combination products that include a device constituent part.

The guidance notes that as part of FDA’s evaluation of an application, it evaluates HF study results submitted by sponsors. “This includes data to support the product user interface when submission of such data is warranted,” FDA says. “The URRA is a risk analysis tool used to identify use-related hazards associated with product use and the measures implemented to reduce those risks. The URRA supports the entire HF engineering process and should be considered as part of an overall risk management framework.”

Additionally, the document says a URRA is important to help identify use-related hazards associated with a combination product’s user interface design, as well as to characterize risks to mitigate them through risk controls or eliminate them altogether through improved product user interface design. The URRA is also a key component in developing an HF validation study protocol and “informing the acceptability of residual risks,” it says. It may also aid in demonstrating compliance with applicable combination product requirements.

The draft guidance recommends that sponsors should initiate the URRA early during product development and use and update the tool in all phases of the product lifecycle (e.g., as the product design changes or as new risks are identified during development or post marketing).

FDA notes that a URRA should include the following:

A comprehensive list of all tasks required for using a product
The potential use errors and harms that may occur with those tasks
A determination of whether each task is a critical task
Risk controls employed in the user interface design to mitigate the use errors
Evaluation methods that have been used (or will be used) to evaluate risk controls’ effectiveness

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