The US Food and Drug Administration (FDA) on Wednesday issued two revised draft guidances for generic drug submissions that use transdermal and topical delivery systems (TDS). The revised guidances make numerous technical clarifications that abbreviated new drug application (ANDA) sponsors should consider when filing their premarket application.
The revised documents update previous draft versions issued in 2018 and shed light on the agency’s evolved thinking on how generic drug TDS products should be evaluated. (RELATED: Latest Batch of FDA Product Specific Guidances Focus on Topical, Transdermal Drugs, Regulatory Focus, 9 October 2018)
In the first guidance, which addresses assessing adhesion for TDS products, FDA said it is updating the document to clarify the appropriate methods sponsors should consider when measuring the surface area of the TDS product that is expected to adhere to a patient’s skin and how to statistically analyze that data…
