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US Food and Drug Administration (FDA)


Report Title: Frequently Asked Questions
Report ID: 488
Date: 6/28/2010
Report Type: Webpage
URL: [default.htm]
Country: United States of America
Organization: US Food and Drug Administration (FDA)
Summary: This webpage from the FDA contains a list of frequently asked questions and answers regarding nanotechnology and the FDA's role in its regulation. Although the FDA has not established a definition of nanotechnology, it participated in the National Nanotechnology Initiative (NNI)'s development of a definition. Existing requirements are anticipated to be effective for most nanotechnology products subject to FDA regulation. Some nanotechnology-containing products, such as cosmetics, are outside of the FDA's regulatory scope. However, it is anticipated that there will be new nanotechnology products and these are likely to be in "combination form" (i.e. drug-device, drug-biologic, device-biologic products). For combination products, a specific sector of the FDA will be assigned primary regulatory jurisdiction, depending on the "primary mode of action" of the product. Approval will be obtained either through a single application or through separate applications, depending on the jurisdiction and safety/effectiveness concerns.
Archived Copy: FAQ_488_8072.pdf



Report Title: Memorandum of Understanding Between the Food and Drug Administration, National Center for Toxicological Research, and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, for Toxicity of Nanomaterials
Report ID: 486
Date: 8/27/2009
Author: US Food and Drug Administration (FDA)
Report Type: Notice
Publication: Federal Register, Vol. 74, No. 165
URL: [E9-20634.pdf]
Country: United States of America
Organization: US Food and Drug Administration (FDA)
Summary: The Food and Drug Administration (FDA) has signed a memorandum of understanding (MOU) with an Air Force Research Laboratory to facilitate information sharing in the areas of toxicogenomic and computational toxicology research. The parties intend to coordinate their research efforts in developing new tools and technologies to understand the biological response to environmental stressors, including nanomaterials. The research objectives include studying nanomaterials and the blood-brain barrier, identifying appropriate biosignatures of exposure to nanomaterials, identifying computational methods of understanding biological responses to exposure, and producing publications in peer-reviewed scientific journals. This notice from the Federal Register contains a copy of the entire memorandum, which will last for 36 months unless the parties choose to extend or cancel it.
Archived Copy: E9-20634_486_4619.pdf



Report Title: Summary Minutes of the Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Report ID: 212
Date: 7/22/2008
Author: US Food and Drug Administration (FDA)
Report Type: Meeting Minutes
URL: [2008-4370m1-Final%20Minutes.pdf]
Country: United States of America
Organization: US Food and Drug Administration (FDA)
Summary: This document is the summary minutes for the July 22, 2008 meeting of the FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. The first topic at this meeting was nanotechnology in drug manufacturing, drug delivery, and drug products. The committee was evenly divided on whether the Committee for Drug Evaluation and Research (CDER) needed to provide guidance for the development of nanotechnology derived drug applications. Members felt that insufficient information about nanotechnology drug products existed to be able to provide guidance at the present time. If guidance was needed, a consensus existed that it would need to focus on the unique characteristics of such compounds, biodistribution, how safety may be different than that of traditional drug products, and environmental consequences. The committee also found that a definition of nanotechnology (for defining which products need guidance) should be based upon intended and unintended functionality of the drug, the differences between altering existing products and creating new materials, and changes which may occur if an existing production process is altered.
Archived Copy: FDA Advisory committee 2008-4370m1-Final Minutes_212_1645.pdf



Report Title: Consideration of FDA-Regulated Products That May Contain Nanoscale Materials
Report ID: 107
Date: 8/7/2008
Report Type: Notice
URL: [FDA-2008-M-0416-nm.pdf]
Country: United States of America
Organization: US Food and Drug Administration (FDA)
Summary: The Food and Drug Administration (FDA) is announcing a public meeting and a request for comments including available data to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report (the Report) relating to the development of agency guidance. The Report's recommendations covered foods (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices. In addition to requesting comments in response to the questions in this notice and those that will be discussed at the public meeting, FDA is announcing a request for available data and information on the effects of nanoscale materials on quality, safety, and, where relevant, effectiveness of products subject to FDA oversight.



 
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