Drugs

Testicular Toxicity Draft Guidance

FDA has issued a draft guidance, Testicular Toxicity: Evaluation During Drug Development, to assist sponsors who are developing drug products that may have potential adverse effects on the testes, referred to by FDA as testicular toxicity, based on findings in non-clinical studies. The document discusses:

non-clinical findings that suggest risk of clinical testicular toxicity, and further non-clinical assessments that may be necessary to evaluate the extent of the risk;
clinical monitoring that can be employed when the drug products are initially administered to men; and
the design of a clinical trial that has as its primary purpose the evaluation of drug-related testicular toxicity.

The guidance provides general considerations for when clinical trials to assess the risk of testicular toxicity may be needed, but does not cover all possible scenarios that would prompt such a trial. It also does not discuss regulatory actions that the agency might consider based on the trial results.

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