FDA nimmt eine passive Haltung bezüglich Nanotechnologie-Richtlinie ein
Wie FDA Week berichtet hat die Food and Drug Administration an einer Sitzung Ende des letzten Monats keine Übereinstimmung bezüglich möglicher Richtlinien für Nanomaterialien erzielen können. Die Task Force der FDA für Nanotechnology traf sich am 22. Juli 2008, um die Erstellung einer solchen Richtlinie zu erwägen, konnte sich jedoch auf keinen Konsens bezüglich der Notwendigkeit oder des Inhalts derselben einigen. Artikel in Englisch:
The primary disagreement appears to be whether to issue a policy at all, or rely on existing statutory and regulatory controls. As one might expect, the panel was split on this issue, resulting in no action in the short term. The split was right down the middle with 5 panel members voting in favor of a policy, 5 voting against, and 1 abstaining.
The panel did agree that FDA should collaborate with OSHA and EPA should either agency begin drafting a policy concerning nanoparticles. FDA will hold a public meeting in September to discuss particle size in drugs and how to obtain such information from its current database. FDA's inaction is not wholly surprising given the state of nanotechnology regulation. However, the even split was somewhat unexpected. The debate seems to center around the data submissions by companies seek FDA approval on products and what is already required. […]
Quelle:
Nanotechnology Law Report