Drugs

Drug-Device Combo Firms Quiz FDA on Specs

The Combination Products Coalition (CPC) says its members have recently experienced FDA requesting that combination product manufacturers demonstrate how they have “validated” device user interface specifications in the intended user population. A CPC statement says its member companies are not aware of any agency guidance or recognized consensus standards that describe the expectation to validate device user interface specifications. Also, it says, FDA requests for evidence of how specifications have been validated appear to be a new request for the premarket review of both combination products and traditional medical devices.

CPC says its members are concerned that:

FDA has not fully defined its expectations for how combination product manufacturers should demonstrate that specifications have been validated;
the requests appear to be new and not associated with any agency regulation, guidance, or policy statement;
the requests appear to be specific to CDER-led combination product reviews and not asked as part of traditional CDRH-led medical device premarket reviews;
the text of the requests received seems in some cases to imply that combination product manufacturers should use usability testing to validate specifications across the full user population capability range; and
the text of the requests received seems in some cases to ask that sponsors design devices to accommodate a subpopulation of the intended users instead of setting device specifications broadly to suit the entire intended user population.

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