Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards has recently been affected by the legal requirement for the FDA to standardize the regulatory approach to ophthalmic products whose components are considered devices. The agency communicated the update through a guidance outlining the phase-i...

Nitrosamines in pharmaceuticals have been of special concern since their presence at unacceptable levels in popular medicines was highlighted in 2018. Since then, improved understanding of their chemistry has enhanced the risk assessments, testing, and mitigation steps required to help minimize nitrosamine contamination in drug substances, excipients, and drug products. In addition, regulatory authorities have largely harmonized requirements and allowable limits in their r...