18 December, 2017
The United States Federal Drug Administration has published a draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials on 18 December 2017.
This Guidance for Industry outlines potential risk factors for drugs containing nanomaterials. It also provides recommendations on quality aspects, environmental impact as well as guidance for both non-clinical and clinical testing.
The document is now open for public comments for a period of 90 days, closing on 19 March 2018.
Please follow this link to access the consultation docket on Regulations.gov, and this link to download the draft Guidance.
NIA Members will be invited to contribute to the NIA Comments to this US FDA Consultation.
