Drugs

Drug Delivery Device Guidance

FDA has published a draft guidance, Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products, describing the agency’s recommendations related to the device design outputs that are essential for establishing and assessing drug delivery performance in medical devices and combination products. The document includes recommendations for the information and data to submit in investigational, marketing, and post-market change applications.

The guidance recommends an approach to identifying essential drug delivery outputs (EDDOs), provides examples of EDDOs for specific types of devices, and describes the information and data related to EDDOs provided in an application.

Device drug-delivery performance information is intended to demonstrate that the device drug-delivery function consistently performs as intended, FDA says. The agency says it is providing recommendations for development and organization of the information and the data to improve the consistency of the information in applications. “Ultimately,” it says, “these recommendations are intended to facilitate and streamline development of drug delivery devices.”

The draft includes an Introduction, Scope and Definition, Background, Overview of EDDO Processes, Identifying EDDOs, Verifying and Validating EDDOs, Control Strategies for EDDOs, Information to Provide in Applications, and four Appendices.

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