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This guidance discusses what types of information you, the applicant, should submit in your new drug application (nda) or abbreviated new drug application (anda) for a liposome drug product. Quality considerations and control for drug products containing nanomaterials from doxil to onpattro Throughout the report, we describe new therapies cder approved in 2024 for safety and eficacy, as well as the regulatory tools used to streamline the review and approval of these applications.
This guidance document is one of several. The table below is a list of cder’s novel drugs approvals for 2024. Provide the agency’s current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage.
Cder’s novel drug approvals for 2024 are listed below
For more information, download the report
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