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Drugs may be covered by multiple patents or regulatory protections This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. All trademarks and applicant names are the property of their respective owners or licensors.

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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. The orange book downloadable data files are updated. This guidance document is one of several.

Otr is addressing challenges associated with developing new drugs using nanotechnology, and is establishing clear standards to pave the way for approval of future generics containing.

We advise manufacturers to consult with the fda early in their development process to facilitate a mutual understanding of the scientific and regulatory issues for their nanotechnology. Want to know what's new on drugs from fda See the latest on topics including Drug approvals, safety warnings, drug shortages, and more.

To download the orange book product information into a spreadsheet that can be searched by additional fields see the download instructions