FDA proposed creating four reporting categories (instead of the current three). Among other proposed amendments: Changes to a container and closure system that may affect the purity of a drug require submission of an SNDA and prior FDA approval. Changes that are not expected to affect the quality of the drug require submission of an SNDA at least 30 days prior to making the change (but not FDA prior approval, a relaxation of the current rule), unless they are specifically covered in another category. The proposal indicates FDA has heightened its reporting requirements for changes within containers and closure systems for sterile liquid drugs, while relaxing reporting requirements for changes to containers and closure systems for nonsterile liquid and solid-dose forms.
Drug packaging regs
Packaging for an approved new drug may be affected by FDA's proposed amendments to its new drug regulations. At issue is when any change to an approved new drug requires the filing of a supplemental new drug application (SNDA), when FDA prior approval is needed, and when a notice in an annual report is sufficient.