Drugs

Transdermal Irritation/Sensitization Assessment

FDA has published a draft guidance, Assessing the Irritation and Sensitization Potential of Generic Transdermal and Topical Delivery Systems for ANDAs, with recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed drug transdermal or topical delivery system (TDS). The document says its recommendations relate to studies submitted in support of an ANDA. It revises a 10/2018 guidance with the same name to (1) clarify recommendations for the design and conduct of studies to evaluate the in vivo skin I/S potential of a proposed TDS; (2) clarify when an in vivo study to assess the sensitization potential of a TDS product may not be needed; and (3) provide guidance to applicants intending to use alternative scoring scales or alternative approaches to compare I/S between the test and reference TDS.

The agency also issued a draft guidance on assessing adhesion with TDS for ANDAs. It says the two drafts were published to provide clear, convenient information to current and potential ANDA applicants as outlined in the agency’s Drug Competition Action Plan.

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