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Tag Archives: FDA

International Center for Technology Assessment et al v. Hamburg

On December 21, 2011, the International Center for Technology Assessment (ICTA), along with fellow plaintiffs Friends of the Earth (FOE), the Center for Environmental Health, Food and Water Watch, the Institute for Agriculture and Trade Policy, and the Action Group on Erosion, Technology and Concentration filed a complaint in the US District Court for the District of Norther California … Continue Reading

FDA Public Workshop on Medical Devices & Nanotechnology

Monday’s federal register carried a notice from the Food & Drug Administration (FDA) announcing a public workshop on "Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations" to be held September 23 2010, from 8AM to 5PM at the Hilton Washington DC/North Gaithersburg, in Gathersburg, MD. Persons interested in participating in the workshop need to register by … Continue Reading

Reporting Format for Nanotechnology Related Information in CMC Review

Recently, the Center for Drug Evaluation and Research (CDER)  Office of Pharmaceutical Science issued the above entitled addition to CDER’s Manual of Policies and Procedures(MAPP). This produced some uproar in the nanotech community by some who interpreted a single line as indicating that the FDA was about to start redefining nanomaterials. The purpose of this new MAPP … Continue Reading

New Edition of Nanotechnology Law Report

Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more): EPA Issues Significant New Use Rules for Carbon Nanotubes Are Nanoparticles Released by Cutting or Compounding Nano-Composites? Annual Nano TiO2 Production Estimated at 44,000 Metric Tons Are Nano Consumer Products Headed Underground? Oversight of Next Generation Nanotechnology … Continue Reading

FDA Announces Collaborative Effort with Alliance for Nanohealth

 Last week the FDA posted a press release on the news section of announcing a "collaboration initiative" with the Alliance for Nanohealth ( . The press release may be accessed at FDA and ANH will work together "to expand knowledge of how nanoparticles behave and affect biologic systems  and to facilitate the development … Continue Reading

FDA Public Meeting to Discuss Task Force Report

The Food and Drug Administration has announced its next public meeting to discuss the results of the Nanotechnology Task Force report.  The meeting is September 8, and any comments on the Report are due by August 24.  The meeting will be held at University Systems of Maryland. The meeting agenda is posted online, and the session … Continue Reading

Confusion at the FDA

FDA Week is reporting that a meeting at the Food and Drug Administration late last month failed to result in any agreement about a possible policy on nanomaterials.  The FDA Nanotechnology task force met on July 22, 2008 to consider the creation of a policy for nanomaterials, but failed to come to any consensus on … Continue Reading

Recommendations for New Nano-Specific Regulation

As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January. J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, … Continue Reading

Report on Food Packaging

Earlier this week the Project on Emerging Nanotechnologies and the Grocery Manufacturers Association released the report, Assuring the Safety of Nanomaterials in Food Packaging.  The report addresses the growing concern of using nanomaterials in food packaging and related applications.… Continue Reading

New York Times Editorial On FDA

This morning’s New York Times features an editorial discussing Peter Barton Hutt’s before the House subcommittee responsible for FDA oversight.  Mr. Hutt warned that the FDA was "barely hanging on by its fingertips;"  others testifying before the subcommittee suggested the agency lacked funds and staffing to do its job: In a hearing before a House … Continue Reading

FDA Regulation of Nanotechnology?

By Tim Cahill: Yesterday the FDA’s Nanotechnology Task Force released its report on the scientific and regulatory challenges related to the use of nanotechnology in products regulated by the FDA. As reported in our July 10, 2007 post, the Task Force’s report did not call for additional FDA regulatory authority in this area. The Task … Continue Reading

No Nano Regulation by FDA?

By: Tim Cahill and Michael Heintz: FDA Week reported on July 6, 2007 that the FDA’s Internal Nanotechnology Task Force is close to issuing its first report and is going to recommend that the agency not create "regulatory policies" for nanomaterials.  Instead, the task force is likely recommending that FDA create guidelines for "best practices."  The Task Force … Continue Reading

Former FDA Official Calls for Increased FDA Nanotech Authority

By Tim Cahill: The April 20, 2007 edition of FDA Week reports that the former deputy commissioner in the FDA’s policy office, Michael Taylor, repeated his call for Congress to grant FDA enhanced regulatory authority with respect to products that utilize nanotechnology, particularly cosmetics, dietary supplements, and foods. Mr. Taylor believes that FDA should have … Continue Reading

New Report Warns of Nanotechnology Risks in Cosmetics

By Tim Cahill: On February 20, 2007, the Investor Environmental Health Network ("IEHN") issued a report entitled "Beneath the Skin: Hidden Liabilities, Market Risk and Drivers of Change in the Cosmetics and Personal Care Products Industry." IEHN represents 20 investment organizations with $22 billion under management that are seeking to ensure that the companies they … Continue Reading

Report by Former FDA Official Urges Greater Regulation of Nanoindustry

An October report authored by Michael R. Taylor, Esq., former FDA Deputy Commissioner for Policy (1991-1994) may not be warmly received by all nanomanufacturers. Taylor’s report focuses on what he sees as FDA’s three primary purposes in relation to nanotechnology: (1) ensure product safety; (2) foster innovation; and (3) maintain public confidence in nanoproducts.  Taylor … Continue Reading

Review: “Nanotechnology and the FDA,” in Nanotechnology Law & Business

In the September 2006 edition of Nanotechnology Law & Business, two (2) employees of FDA’s Center for Drug Evaluation and Research (“CDER”) — Nakissa Sadrieh and Parvaneh Espandiari — published “Nanotechnology and the FDA: What Are the Scientific and Regulatory Considerations for Products Containing Nanomaterials?” The article begins with a disclaimer that the authors’ views … Continue Reading

Expert Says FDA Should Ensure Capacity to Address Nanoapplications

In a recent presentation to FDA, David Rejeski, Director of the Woodrow Wilson Center’s Project on Emerging Nanotechnologies, stated “there are currently 130 nano-based drugs and delivery systems and 125 biomedical devices in preclinical, clinical or commercial development.”  Of these, Rejeski identified 77 cancer-related drugs and 56 drug delivery applications.  Rejek also stated that the … Continue Reading