Drugs

Turner Scientific Wants Its Ototoxicity Draft Guidance Issued

Turner Scientific has petitioned FDA to approve and issue a proposed guidance drafted by Turner on nonclinical evaluation of ototoxicity during drug development. The petition says that Turner believes that current regulatory requirements “do not lead to adequate detection and prevention of harm to hearing and balance caused by medication use, and that the potential for clinically significant damage to hearing and balance is underappreciated.”

The proposed guidance is intended to assist sponsors who are developing drug products that may have potentially adverse effects on auditory organs and structures. It discusses (1) the importance of ototoxicity testing and the current state of FDA regulations on ototoxicity; (2) a proposed standard test battery for nonclinical ototoxicity assessment, and additional tests that should be considered based on the specific compound(s) being developed; and (3) considerations for designing nonclinical ototoxicity studies.

The document says it focuses not only on nonclinical testing of drugs with the potential to cause unintended and harmful effects on auditory function, but also on drugs that are being developed with the intention of preventing or treating diseases or conditions related to auditory function.

Turner says that despite the fact that ototoxic side effects are very common among currently marketed drugs, there is little regulatory incentive for drug manufacturers to assess the ototoxic potential of new drug products. And while routine ototoxicity screening should be a logical priority for drug manufacturers, it says, “it is unlikely that they can be relied upon to comprehensively test their products for such side effects.”

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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