New Guidelines for Nanomaterials reflected in Presentations at Joint Conference on Nano Formulations

In two recent news you could read that the FDA published Draft Guideline on Use of Nanotechnologies for Biological Medicinal Products and that the WHO published a Guideline on Worker Safety relating to Nanomaterials.

The WHO Guideline states that "The recommendations are intended to help policy-makers and professionals in the field of occupational health and safety in making decisions about the best protection against potential risks specific to MNMs in workplaces. These guidelines are also intended to support workers and employers. However, they are not intended as a handbook or manual for safe handling of MNMs in the workplace because this requires addressing more general occupational hygiene issues beyond the scope of these guidelines."

The FDA defines the scope of their new Guideline as follows: "This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial (as explained in this section) is present in the finished dosage form. This guidance focuses on considerations relevant to FDA’s regulation of these drug products under the Federal Food, Drug, & Cosmetic Act (FD&C Act) and Public Health Service Act (PHS Act), and includes recommendations for applicants and sponsors of  investigational, premarket, and postmarket submissions for these products."

Taking up these developments, speakers at the Nano and Micro Formulations Conference on 13/14 March in Berlin, Germany,  will include information about the current regulatory guidelines and recommendations in their presentations and provide you with the possibility  to discuss their impact with speakers and colleagues. The FDA guidelines will be a part of the presentation of Dr Xiaoming Xu , Center for Drug Evaluation and Research, U.S. FDA. Dr Tobias Schulz from Rittershaus Attorneys will cover the WHO guidelines in his presentation.

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