Drugs

Transdermal and Topical Adhesion Assessment Guidance

FDA has issued a draft guidance, Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications, with recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical delivery systems. The document says adhesion performance can affect both safety and effectiveness of transdermal and topical delivery systems because adhesion failures can result in reduced effectiveness caused by suboptimal dosing or potentially increased exposure when a new system needs to be applied sooner than the scheduled dose.

Also, the guidance says, partial or full detachment of a system from a patient’s skin may result in unintentional exposure of the active pharmaceutical ingredient to a partner, child, or other individual, potentially exposing them to the drug’s toxicity.

The guidance recommendations relate to studies to be submitted in support of a NDA or sNDA for human prescription and nonprescription drug products. FDA says biological products are outside its scope because they are often more complex and of a higher molecular weight, making it likely they would not be absorbed across the skin, requiring a different approach for administration.

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