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...

Information about FDA guidance documents on topics relating to the application of nanotechnology in FDA-related products.

FDA will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction.

Contents … science activities and issues related to FDA-regulated products that either contain nanomaterial or otherwise … or tools needed to make regulatory assessments of these products.

Our 2024 drug approvals include therapies for a variety of diseases and conditions, including rare diseases.

FDA anticipates that nanotechnology may play a critical role in the design, development, and manufacture of next-generation products – including drugs, medical devices, and foods.

The FDA regulatory science program is completing work to foster the responsible development of FDA-regulated products that may contain nanomaterials or otherwise involve the application...

Jul 14, 2025 · CDER’s novel drug approvals for 2024 are listed below. For more information, download the report. The table below is a list of CDER’s novel drugs approvals for 2024.

This assessment focused on such broad questions as whether FDA can identify products containing nanoscale materials, the scope of FDA’s authorities to evaluate the safety and …

Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products , including those that are biological products . 3 Nanotechnology may be used to...