Nanotech Roundup: Latest National Nanotechnology Initiative Strategic Plan Released for Comment - FDA Law Blog

FDA Law Blog: Nanotech Roundup: Latest National Nanotechnology Initiative Strategic Plan Released for Comment; NYAS Nanomedicine Conference Summary:

"The draft plan lays out the NNI’s goals and objectives, which remain largely unchanged from 2011 (see here). As with the 2011 Plan, the draft 2014 Plan includes a description of FDA’s NNI-related activities. Those activities continue to be primarily focused on the goal of supporting responsible development of nanotechnology. However, the 2014 Plan more explicitly recognizes the potential impact of nanotechnology on the status of FDA-regulated products:" . . .

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Reputable Mesothelioma Resources

Updated February 24, 2021

Some links just don't age well.

You might also be interested in:

Mesothelioma - Mayo Clinic

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I've recently started to read more about mesothelioma and asbestos. I'm finding out that it's very difficult to discern what is really objective and balanced information. Here's a resource that I believe to be credible from a well-respected healthcare provider, Kaiser Permanente, "Mesothelioma." On this page, there's a good list of additional and reputable resources to explore.

What's your experience in finding fair and balanced information? Can you suggest some credible and reputable websites?

Related Posts:
Are Nanoparticles Dangerous Like Asbestos?

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Are Nanoparticles Dangerous Like Asbestos?

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Updated October 15, 2022:

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GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

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Updated January 9, 2021

Speaking of nanoparticles, you might also be interested in:

Fact check: Lipid nanoparticles in a COVID-19 vaccine are there to transport RNA molecules - Reuters

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More recent news buzz on the topic recently. When I see nanotechnology, or nanoparticles, I'm worrying about whether we're creating a wave of manmade asbestos-like materials and ensuing mesothelioma. I stumbled across this on the NIOSH site, and think you'll find it an interesting read. Coming from NIOSH, I'm more likely to believe what I read, "Approaches to Safe Nanotechnology - Managing the Health and Safety Concerns Associated with Engineered Nanomaterials." The document reviews what is currently known about nanoparticle toxicity, process emissions and exposure assessment, engineering controls, and personal protective equipment. This updated version of the document incorporates some of the latest results of NIOSH research, but it is only a starting point. The document serves a dual purpose: it is a summary of NIOSH's current thinking and interim recommendations; and it is a request from NIOSH to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information that will ensure that no worker suffers material impairment of safety or health as nanotechnology develops. 

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FDA Collaborates On Nanotech Initiative

The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. I'm glad to see this. Until nanotechnologies are better and more deeply understood, it makes sense to me that the best minds thinking about nanotech are collaborating. More FDA Information: FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative - Overarching goal: developing an efficient pathway for safe and effective nanoengineered medical products 

Related Posts: Should The FDA Oversee Nanotechnology Dietary Supplements? Go For Gold - I Mean Nanoparticles And Drugs FDA - FAQs About Combination Products 

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Should The FDA Oversee Nanotechnology Dietary Supplements?

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Updated October 15, 2022:

Some links broke.

You might also be interested in:

GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

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If you read this Project On Emerging Nanotechnologies publication, you'll probably say yes, A Hard Pill to Swallow - Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements. Historically, the regulation of dietary supplements has been a significant challenge for the U.S. Food and Drug Administration (FDA), and the fact that some of these products are now being manufactured using nanotechnology creates an additional layer of complexity. The use of engineered nanoparticles in dietary supplements raises serious questions about whether such products are safe. Congress has generally allowed dietary supplements to be marketed without any pre-market demonstration of safety, based largely on the assumption that these products have been used for many years. There is, however, no basis for concluding that dietary supplements containing engineered nanoparticles are safe. The authors ask, "Is FDA equipped to meet the emerging regulatory challenge of dietary supplements that use engineered nanomaterials?" Here's their conclusion . . .

• There is no basis for concluding that dietary supplements containing engineered nanoparticles are safe.
• While it is not possible to determine the prevalence of dietary supplements containing engineered nanoparticles, it is likely that the public’s exposure to these products will grow significantly in the next several years. Congress should adopt legislation granting FDA the authority to collect additional information about these products and to ensure that they are tested for their effects on human health. Such legislation should prohibit the sale of new dietary supplements containing engineered nanoparticles until they have been demonstrated to be safe, and it should provide FDA with sufficient resources to regulate these products.
• Until Congress acts, consumers who take dietary supplements containing engineered nanoparticles will be at additional, unknowable, and potentially serious risk.

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Go For Gold - I Mean Nanoparticles And Drugs

Updated June 16, 2025

The original link broke.

You might also be interested in this FDA webpage:

https://www.fda.gov/about-fda/nctr-research-focus-areas/nanotechnology

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This just caught my eye, Team Designs Gold Nanoparticles to Deliver Multiple Drugs. This is really unusual. Build some gold nanoparticles with drugs stuck on them, and with the right infrared exposure, the gold releases the drugs. The MIT research team reports that when exposed to infrared light, the gold nanoparticles melt, releasing drug payloads attached to their surfaces. They built two different shapes of nanoparticles, called "nanobones" and "nanocapsules." Nanobones melt at light wavelengths of 1,100 nanometers, nanocapsules at 800 nanometers. The team thinks this technique could one day provide more control of diseases commonly treated with more than one drug, by attaching mulple drugs to the surface of the nanoparticles.

Very cool, don't you think?!

More Infomation:
FDA and Nanotechnology Products - FAQs

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FDA And Future Nanoscale Drug Regulation

The future is here. The FDA is starting to wrestle with how to regulate the burgeoning area of nanoscale drug development. This is pretty fascinating and interesting stuff as reported in this American Society of Health-System Pharmacists (ASHP) news article, "FDA Gathers Information For Plans To Regulate Nanoscale Drugs." Here are a couple of things I found interesting . . .

1. Existing methods for examining traditional-sized products may fall short at the nanoscale level
2. There's a need to understand the potential benefits and hazards of smaller drug particles
3. At what size does a drug become a nanoscale product?
4. Nanoscale drugs are manipulated in ways that may change the chemical and physical properties of a substance, which may alter how the drug functions inside the body

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