Dear Ruba Ismail,

" Drug Products, Including Biological Products, that Contain Nanomaterials" draft guidance could be useful

https://www.fda.gov/media/109910/download

Please check others:

https://www.fda.gov/science-research/nanotechnology-programs-fda/nanotechnology-guidance-documents

In FDA guidance you can find:

- Factors for Assessment of the Nanomaterial

- Nanomaterial Quality Attributes and Structural Characterization (in CMC part)

hope it helps,

Best regards,

Tomasz

Dear Tomasz Grabowski,

Thank you very much for your valuable response. This is really useful for me since I am working on QbD driven design of nanosystems for peptides delivery.

Kind regards,

Ruba