[PDF][PDF] FDA and Nanotechnology Regulation

MP Advisory - THE JOURNAL OF NUCLEAR MEDICINE, 2011 - Soc Nuclear Med
The US Food and Drug Administration (FDA) on June 9 released draft guidance to provide
regulated industries with greater certainty about the use of nanotechnology. The guidance …

FDA and nano: baby steps, regulatory uncertainty and the bumpy road ahead

R Bawa - Handbook of Clinical Nanomedicine: Law, Business …, 2016 - books.google.com
Emerging technologies bring with them concerns and uncertainties about how they should
be regulated [1]. Clearly, when these technologies relate to human healthcare, regulation in …

FDA's First Major Nanotech Plan Focuses On Safety, Potency Research

S Ditta - Inside Washington's FDA Week, 2010 - JSTOR
FDA Week is published every Friday by Inside Washington Publishers, PO Box 7167, Ben
Franklin Station, Washington, DC 20044. Subscription rates: $685 per year in US and …

[HTML][HTML] Regulation of nanotechnology: Are we doing enough?

TJ Webster - International Journal of Nanomedicine, 2007 - Taylor & Francis
As such, a number of excellent recommendations were made through this task force. They
specifically dealt with requesting data and other information from those wishing to market …

Physicochemical Properties of Nanomaterials Relevant to Medical Products

BV Chikkaveeraiah, SG Malghan… - … -Chemical Properties of …, 2018 - taylorfrancis.com
This chapter focuses on medical devices distinct from the larger universe of drugs, biologics,
and foods that constitute the portfolio of regulatory responsibilities of the US Food and Drug …

[HTML][HTML] Report of the AAPS guidance forum on the FDA draft guidance for industry:“Drug products, including biological products, that contain nanomaterials”

JSB de Vlieger, DJA Crommelin, K Tyner… - 2019 - Springer
To guide developers of innovative and generic drug products that contain nanomaterials, the
US Food and Drug Administration issued the draft guidance for industry titled:“Drug …

Should FDA Regulate Nanomedicine Differently?

B Culliton - Health Affairs Forefront, 2008 - healthaffairs.org
Barbara Culliton: Nanomedicine is the" next big thing" in medicine, following fast on the
heels of developments in genomics and the other"-omic" sciences.... Are drugs or devices …

Summary report of PQRI workshop on nanomaterial in drug products: current experience and management of potential risks

JA Bartlett, M Brewster, P Brown, D Cabral-Lilly… - 2015 - Springer
Abstract At the Product Quality Research Institute (PQRI) Workshop held last January 14–15,
2014, participants from academia, industry, and governmental agencies involved in the …

[CITATION][C] Nanomedicine: Prospects, Risks and Regulatory Issues

N Ross

[CITATION][C] FDA Declines Defining Nanotech In New Guide

S Ditta - Inside Washington's FDA Week, 2011 - JSTOR