United States

US FDA publishes Draft Guidance for Industry on Drug Products, Including Biological Products, that Contain Nanomaterials

The United States Federal Drug Administration has published a draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials on 18 December 2017.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.

United States Registration Scheme Goes Live – Guidance document Released

The United States Environmental Protection Agency (EPA) rule on Chemical Substances When Manufactured Or Processed As Nanoscale Materials; TSCA Reporting And Recordkeeping Requirements has entered into force on 14 August 2017. It is now supported by a working guidance which clarifies the requirements of the rule.

US NIOSH opens consultation on Health Effects of Occupational Exposure to Silver Nanomaterials Publication

Late January 2016, the US National Institute for Occupational Safety and Health (NIOSH) has released a draft document on the Health Effects of Occupational Exposure to Silver Nanomaterial. This document contains a literature review as well as recommendations for the safe handling of silver nanoparticles and research needs to fill in data gaps and is now open for comments with a deadline on 21 March 2016.