NEWS | FDA Guidance update

This new directive primarily concerns medicinal products applied to the skin (cutaneous products) but may also be applicable to other locally acting drugs, such as preparations for auricular (ear), ocular (eye), or vaginal use. The guideline aims to streamline and enhance the regulatory framework governing the quality and equivalence of these topical medications.

This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The guidance also describes conditions that may introduce nitrosamine impurities. The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.