Biologics

Workshop on Patch Tests for Allergic Contact Dermatitis

FDA is hosting a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic contact dermatitis (ACD) — a common inflammatory skin condition affecting millions of Americans. The virtual workshop is intended to bring together regulators, clinicians, academic researchers, and industry stakeholders to examine how the agency reviews and licenses patch tests and whether new, more flexible regulatory approaches are needed.

FDA said the goal of the event is to “gain perspective” from experts and the public on the regulatory status and approval process for new patch test allergens.
Key objectives include:

Providing updates on the current regulatory framework for patch tests used to diagnose ACD.
Reviewing current diagnostic methods and approval pathways in the U.S. and abroad.
Considering alternative approval mechanisms — including the use of real-world data — that could help speed access to new allergen panels.

The agency noted that feedback from this workshop “will help inform the need for rapid approval of new patch test allergens, the utility of the agency’s current approval paradigm, and proposals for alternative approaches that might be considered.”

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

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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