Biologics

Workshop on Allergic Dermatitis Patch Test Alternatives

FDA is announcing a 10/23 public workshop to discuss the regulatory status of patch tests used in diagnosing allergic contact dermatitis (ACD). The CBER-directed one-day virtual event is intended to gain stakeholder input on current approval requirements and potential alternative approaches.

Patch testing is the only validated method for diagnosing ACD, but FDA notes that the limited number of allergens available in pre-prepared test panels can hinder diagnosis, according to a meeting notice. New panels are regulated as biologics and require a BLA with placebo-controlled trial data, a process some stakeholders argue is costly and restrictive.

International regulators, including the European Medicines Agency, have adopted alternative models such as reliance on real-world data. FDA says input from the workshop will inform its evaluation of whether similar approaches may be appropriate in the U.S. Meeting topics will include the burden of ACD, diagnostic tools, approval paradigms, unmet needs, and regulatory requirements in the U.S. and European Union.

The workshop will be held virtually via Microsoft Teams. Registration is available online here.

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