Category Archives: Regulatory Science

Early communication: A key to reduced drug development and approval times

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By: Anne Pariser, M.D.

From “test tube” to market typically takes a new drug more than 10 years.  FDA has been working hard at many points along a drug’s developmental path to reduce this time and bring safe and effective new therapies to Americans as efficiently as possible. 

Much has been said about FDA’s success in using its “expedited approval” tools, specifically Priority Review and Accelerated Approval, to support innovative new drugs. These are important tools that FDA can use once a marketing application is submitted. For instance, last year, FDA’s Center for Drug Evaluation and Research (CDER) approved 39 novel medications, almost half of which benefited from one (or both) of these expedited approval tools. According to a recent FDA report, this is a 63% increase over the average number of annual approvals since 2002. 

But less has been said about FDA’s “expedited development” tools, which help foster new drug innovation during the investigational phases of drug research and development, well before a marketing application for a new drug is even submitted to FDA. Among these tools are more frequent and earlier opportunities for communication between FDA and drug developers. FDA’s Fast Track designation for drugs with the potential to address unmet medical needs is an example. For many years, Fast Track has helped speed new drug development by encouraging more communication early in the development process. In 2012, about 40% of CDER’s novel new drug approvals were drugs that were given this Fast Track designation.     

Just this past year, the Food and Drug Administration Safety and Innovation Act (FDASIA) authorized FDA to use a new Breakthrough designation for investigational new drugs when preliminary clinical data suggest that the drug may provide a substantial improvement over existing therapies for patients with serious or life-threatening diseases. The concept behind Breakthrough is that, with increased communication, FDA will work with new drug developers to help design efficient ways to study the safety and effectiveness of their drug. This early assistance can help ensure that the results of clinical trials provide the evidence that FDA must have to determine whether or not a drug is safe and effective for approval. A growing number of drug developers are already taking advantage of Breakthrough.

But even before Breakthrough had been authorized by FDASIA, FDA was working to encourage communication opportunities for drug developers to meet with FDA to help make sure their clinical trial designs and development plans offered the best chances of efficient, safe, and timely development and approval. These opportunities are available at the start of a drug’s clinical development cycle: right before the earliest phases of human testing known as the “pre-investigational new drug (IND) phase” (fittingly called pre-IND meetings) and continue throughout drug development.

Early communication in action

Recently, FDA has taken a look at the development times of new drugs that were approved with the benefit of pre-IND meetings and compared them to the development times for drugs that were approved without such meetings. The findings underscore the value of early communication. For those new drugs for which a pre-IND meeting between the drug developer and FDA was held, average clinical development times were substantially shorter than when a meeting was not held. For instance, for all new drugs approved between 2010 and 2012, the average clinical development time was more than 3 years faster when a pre-IND meeting was held than it was for drugs approved without a pre-IND meeting.

For orphan drugs used to treat rare diseases, the development time for products with a pre-IND meeting was 6 years shorter on average or about half of what it was for those orphan drugs that did not have such a meeting. Early communication is especially important for orphan drugs because these products require special attention and thus early talks can be especially beneficial.

Many factors can influence the speed and efficiency of a drug development program. Nevertheless, FDA strongly believes in the value of effective communication during the drug development and approval process, especially for novel development programs when established regulatory pathways do not exist. FDA is committed to working with drug developers to ensure efficient and effective drug development programs whenever possible.

Thirty-nine novel new drug approvals last year is encouraging – one third of which are indicated to treat rare diseases – and many of these new drugs are now making valuable contributions to public health inAmerica. FDA will continue to do its part to help bring safe and effective new drugs to market as soon as possible. We will continue efforts to enhance communication as a critical part of the drug research, development, and regulatory process – especially since it is so clear that communications can make a big difference.

Anne Pariser, M.D., is Associate Director for Rare Diseases, Office of New Drugs, Rare Diseases Program at FDA’s Center for Drug Evaluation and Research

Supporting Africa’s Capacity to Review and Approve HIV/AIDS Drugs

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By: Beverly Corey, DVM

Sub-Saharan Africa, the portion of Africa that runs from the Sahara Desert to the Cape of Good Hope at Africa’s southern tip, is more heavily affected by HIV and AIDS than is any other region of the world. In South Africa alone, 17.8 percent of the people have HIV. There were an estimated 22.9 million people living with HIV and 1.2 million deaths in Sub-Saharan Africa in 2010.

Against the backdrop of this harsh reality, FDA has played a critical role in helping to ensure the availability of high quality, safe, and effective treatment therapies. The agency has approved or tentatively approved applications for 155 antiretroviral drugs from Dec.3, 2004 to Nov. 8, 2012, thereby making them available for use as part of the President’s Emergency Plan for AIDS Relief, or PEPFAR. This program, begun in 2004, is the U.S.government’s commitment to support HIV/AIDS treatment for millions of people around the world.

It is clear that the supply of medications to treat HIV/AIDS in Africa must be increased.  One necessary way to address delayed access to medications is to bolster the expertise of African regulators so that they can conduct timely reviews of drug applications. After all, the FDA approval or tentative approval is just one step. Then the therapies must be registered (or approved) by competent drug regulatory authorities in the countries of use.

Some resource-constrained low and middle income African countries have lacked sufficient expertise to conduct registrations efficiently. Focusing on generic drugs will be particularly important there, because generics are less expensive than the brand name products.

Recently, as part of a longstanding PEPFAR mandate for FDA to provide drug registration training for African regulators, the agency had the opportunity to spearhead and provide such training.

Let me share with you what we accomplished. FDA, in collaboration with the Kilimanjaro School of Pharmacy and Purdue and Howard universities, provided a five-day course on the review of generic drug applications and PEPFAR drug reviews.

Thirty-seven regulators and academicians from 17 African countries participated. This first-of-its-kind training, held in Moshi, Tanzania, was aimed at enabling regulators and pharmaceutical school faculty to familiarize themselves with regulatory and scientific methods applied by FDA.

The most exciting, complementary aspect of the training was to introduce the value of integrating regulatory science training into the curricula of schools of pharmacy and other academic institutions in Africa.

FDA and its partners believe that this training course can eventually be turned into a teaching module for use in academic curricula throughout Africa. Such curricula can support a cadre of regulatory affairs professionals to work in government agencies. This would further the availability and the manufacture of quality, safe and effective drug products for the African population. 

If we can contribute to a global curricula for regulators, what a legacy that would be, for both PEPFAR and FDA!

Beverly Corey, DVM, is the Senior Regional Advisor for  Sub-Saharan Africa, FDA Office of International  Programs, US Embassy, Pretoria, South Africa

FDA Commissioner’s Global Health Lectureship: Focusing the Lens on Product Safety

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By: Mary Lou Valdez

FDA is responsible for ensuring the safety and quality of tens of millions of foreign shipments of human food, animal feed, medical products and cosmetics that come into the United States every year. Many source countries are part of the developing world that is still forming its economic and industrial base. Thus, we have strong public health interests in making sure that the countries of origin have effective systems of regulatory oversight.

Strengthening the ability of developing countries to regulate their industries could also produce tremendous benefits for the health and quality of life of individuals and communities in those countries. Additionally, the development of stronger regulatory systems in other countries can bolster other U.S. government investments in public health, trade and economic development.  

To enhance FDA’s knowledge of global public health trends, the Office of International Programs launched The Commissioner’s Global Health Lectureship in 2010. The lectureship invites highly respected and recognized leaders in global health to speak to FDA staff, and help the agency explore its role as a public health agency of the 21st century and consider the critical functions of regulatory science and systems that contribute to improved public health. 

Participating thought leaders have included:

  • Julio Frenk, M.D., M.P.H., Ph.D., Dean of the Harvard School of Public Health
  • Margaret Chan, M.D., Director-General of the World Health Organization
  • Sir George Alleyne, M.D., Director Emeritus of the Pan American Health Organization
  • Maria Freire, Ph.D., former President of the Albert and Mary Lasker Foundation and now President of the Foundation for the National Institutes of Health
  • Nils Daulaire, M.D., M.P.H., Director of the Office of Global Affairs, U.S. Department of Health and Human Services
  • Trevor Mundel, M.D., President of the Global Health Program, Bill & Melinda Gates Foundation

These lectures have inspired FDA staff to remain vigilant in protecting U.S. consumers and patients from harmful products, and to take action globally. For example, following Dr. Chan’s lecture, FDA is working with WHO and its member states on a long-term strategy for strengthening the review of applications for new pharmaceutical products and vaccines.  

Similarly, as a result of Dr. Mundel’s lecture, FDA and the Gates Foundation have committed to developing key messages on the strengthening of regulatory systems that the foundation and the agency can consistently and collaboratively deliver to governments and public or private institutions. Here, the Gates Foundation, through its investments in product development partners, supports research and development of medical products to treat diseases affecting poor and vulnerable populations in developing countries. Strong regulatory systems are also essential to ensuring that these products meet science-based quality and safety standards before they are approved for sale, and can be monitored afterwards. The Gates Foundation recognizes the need for regulators to make informed decisions about what products enter their markets. 

Our Global Health Lectureship has provided—and with future speakers will continue to provide—opportunities for FDA staff to engage in issues in new and unique ways, changing the agency’s global lens as we work to expand the product safety net all over the world. To learn more about FDA’s global strategies, read the “Pathway to Global Product Safety and Quality.”     

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

 

FDA and Sub-Saharan Partners Protecting Public Health

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By: Beverly Corey, DVM

FDA and its partners in Sub-Saharan Africa have made great strides in improving the oversight of the clinical trials of medical products in development—an important advance in protecting public health in both the U.S. and Africa.

This is important not only to protect the Africans who are participating in these tests of medical products, but also because the FDA and other regulatory authorities must rely on the results of these studies when reviewing marketing applications for the products.

FDA’s Office of International Programs (OIP) established its Sub-Saharan Africa Post in Pretoria, South Africa, in June 2011. We have been building regional relationships that allow us to share information about FDA policies and procedures, and to better understand the regulatory landscape there. The latter is no small feat in this vast region of 54 countries with varying degrees of regulatory strengths and capabilities.

However, our collaboration with the Southern Africa Development Community (SADC), which represents 15 African nations, has allowed FDA to strategically engage in strengthening regulatory capacity in the area of Good Clinical Practices (GCPs) and clinical trial inspections. These practices, and the inspections to ensure that they are followed, are designed to protect the integrity of data produced by the trial and the safety of its participants.

This activity has given expertise to regulators who did not think their knowledge base was extensive enough to audit (monitor) and inspect clinical trials. Regulators in countries that once did not audit clinical trials are now doing so. With more than 2,000 clinical trials being conducted in Africa—over half of them in South Africa—this is a momentous public health achievement. 

GCP team members meet with the principal investigator and staff at a TB clinical trial site

The Sub-Saharan Africa Post conducted a successful FDA/SADC Good Clinical Practice Inspection training from August 24-28, 2012, in Lusaka, Zambia. Thirty six drug regulators from 13 SADC countries participated, including Angola, Botswana, Lesotho, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe.

This was the third in an FDA training series—typically offered in three to four phases—to develop trainers who have expertise in clinical practices and inspection. These individuals will also be prepared to train others within their agencies and the regulated community.  

This particular workshop was designed to reinforce lessons learned and provide additional inspectional experience for those who completed workshops in the first two training phases in Botswana in 2010 and in Pretoria in 2011. The goals of Phase 3 include reviewing core knowledge and skills, preparing inspection reports and inspectional observations; acquiring additional mock inspection experience at clinical investigator sites; gaining experience with new types of study protocols; and promoting regional networking.

These countries continue to make substantial progress in the oversight of clinical trials. For example, at the onset of our first training, only three of 13 participating countries were involved in how clinical trials are conducted. We now have an additional two countries conducting oversight, with others poised to start soon. Other milestones from our training include important advances towards systematic oversight in Botswana, Mauritius, Swaziland, Tanzania, Zambia and Zimbabwe.

The definitive winner here is public health, both the health of the African people who participate in the trials and the health of the patients who may one day be taking these drugs being studied.

Beverly Corey, DVM, is the Senior Regional Advisor for  Sub-Saharan Africa, FDA Office of International  Programs, US Embassy, Pretoria, South Africa

 

Basing Food Safety Standards on Science and Prevention

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By: Margaret Hamburg, M.D.

Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply.

Margaret Hamburg, M.D.That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.

The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination. 

These rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act (FSMA) and focus on preventing food safety problems before they happen.

These two rules are also part of a larger, ongoing reform effort, with other rules that set similarly high standards for imported and animal foods to be released in the near future.

In our interconnected world, FDA’s vigilance must extend globally. About 15 percent of our food is imported, and in some categories that percentage is much higher. For example, half of our fruits and a fifth of our vegetables come from abroad. We need a strategy that will address all of these complexities and challenges.

In drafting the proposed rules, FDA conducted extensive outreach and talked with key stakeholders, including farmers, consumer groups, state and local officials, and the research community. They build on existing voluntary industry guidelines and best practices for food safety, which many producers currently follow.

We want to continue to engage the public. So, I encourage Americans to review and comment on these rules, which are available for public comment for 120 days.

I believe this also showcases FDA’s adherence to solid science in its policy- and decision-making. The new draft rules recognize that the science of food safety is constantly evolving and that our oversight must take into account issues such as emerging disease-causing bacteria and new understandings of how hazards can be introduced into food processing.

FDA is committed to working with industry to provide the support they need, especially the smallest businesses. That’s why we are working with stakeholders through the Produce Safety Alliance, the Sprouts Safety Alliance, and the Preventive Controls Alliance to continue outreach efforts and to make educational and technical information readily available to industry.

Meeting the public health demands of a global marketplace. Bringing solid science to bear on our decision making. And safeguarding the well-being of American families with a prevention-focused food safety system. That’s FDA at work in the 21st century.

Margaret Hamburg, M.D., is Commissioner of the Food and Drug Administration

What is Regulatory Science?

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What is regulatory science? And what does it mean to you and your family? Listen to top FDA officials and scientists explain the fields of research that make it possible for FDA to fulfill its mission of protecting public health. Regulatory science provides the evidence that FDA needs to know that products such as drugs, medical devices, vaccines, cosmetics and foods are safe for consumers. Regulatory science makes it possible for FDA to evaluate the safety and effectiveness of advancing technology, and to get innovative products to consumers as quickly as possible. It is difficult to count the number of ways in which this research affects the daily life of the average American consumer.

For more information about regulatory science, visit the Consumer Update series on this subject:

Why You Should Care About Regulatory Science

Personalized Medicine Will Fit You Like a Glove

FDA Targets Drug Side Effects

Emerging Technology Embraces the Future

Scientists Working to Keep Foods Safe

Modernizing FDA’s Information Technology

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By: Eric D. Perakslis, Ph.D.

As I look back at my first year as chief information officer and chief scientist (informatics) at FDA, I am gratified with all of the progress that has been made. But I am also eager to transform initial wins into consistent and sustained success.

My team at the Office of Information Management (OIM) manages and advances information technology at FDA. Our mission is to provide the organizational structure and services that allow the exchange of information, communication and knowledge that enhance and sustain FDA’s ability to protect and promote the public health.

Our vision is that FDA’s technology and knowledge capability is modern, secure, accessible, cost-effective, and exceeds customer and partner expectations.

Some of our early successes include important contributions to what we call the Innovation Pathways 2.0 initiative, which provides a rapid new way to submit breakthrough medical devices to FDA for approval. This in turn would get such products faster to the patients who need them.

OIM also completed 20 projects in very short time in support of the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in July 2012. Many of these projects strengthen the process of reviewing and approving important new medical products, while making that process more transparent to the tax-paying public.

In addition, this year we launched a new strategic effort to improve the overall “customer experience” with FDA’s information technology, customers in this case being FDA employees stationed all over the world. Our goal is to provide the technology to ensure that FDA employees can reliably perform their daily duties efficiently and timely regardless of location, whether they’re in an office or in the field, or at home working remotely.

And our improvements to the process of analyzing the health risks presented by medical products of all kinds have helped drive the modernization of the FDA inspection process. This helps ensure that the growing number of products we regulate have a higher level of safety and quality before they reach American consumers.

While these accomplishments are significant, there is still much to be done to modernize information technology at FDA.

The new FDA Information Management Strategic Plan sets the path forward. Its priorities include strengthening real-time connectivity and access to key data and information. This is essential for daily FDA operations and for our connections to the public we serve and to our many partners outside of the agency who depend on FDA for the execution of their own public health missions.

The Strategic Plan also focuses on the availability and usability of data essential to the speed and efficiency of decision-making at FDA. The intent of this goal is to facilitate a learning and knowledge network that will enable FDA to assess the potential risks of regulated products on a scale that routinely handles global sources and large volumes of data. 

Going forward, we will do our best ensure that FDA’s technological needs today and tomorrow are fully covered and in place. There is no more inspirational public health mission than that of the FDA. Every citizen of this great nation depends on us every day and we will never forget that. In many ways this Strategic Plan is as much about what we believe, and our commitment to our customers and mission, as it is about what we deliver.

Eric D. Perakslis, Ph.D., is FDA’s Chief Information Officer and Chief Scientist for Informatics

Regulatory Science Is Not Boring

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By: Susan Kelly

I’m a relative newcomer to government work, joining FDA about 18 months ago after decades of being a journalist. My job is to assign, write and edit FDA Consumer Updates, news stories posted on fda.gov that are designed to give consumers important information in language that’s easy to understand. Not too technical or bureaucratic.

To endear myself to my new colleagues, I decided to write about anything that we saw as boring, leaving them to write about the hotter topics. I’m not easily bored, so I thought this would work as a noble gesture.

Even with this resolve, my heart sank when I was asked to write about regulatory science – one of FDA’s highest priorities. Do you remember the character Chandler Bing from the TV show “Friends”? I could hear his voice in my head: “Could this BE more boring?”

But I resolutely set about my task and five Consumer Updates later, I’m here to tell you that regulatory science is NOT boring. Not even close.

The official definition: “Regulatory science is the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.”

Ok. Put down the remote and give me a minute.

FDA has a huge impact on your daily life. Think about the foods you eat, medicines you take, vaccines your kids are given, the medical devices as commonplace as band-aids and toothbrushes and as complicated as an artificial heart, the foods and medicines you give your pets. FDA’s job is to make sure that products like these, and many, many more, do what they’re supposed to do —and do it safely.

Regulatory science is the proof that’s in the pudding, so to speak. It’s how FDA collects the scientific evidence it needs to determine if a regulated product will actually make your life better. It’s how FDA collects the scientific evidence it needs to ensure that the foods you eat at home or in restaurants are safe to eat. (How they taste is not our problem.)

Regulatory science identifies and tracks nasty bacteria that contaminate food. It creates genetic tests to determine if medication could work for you specifically—not just for people who are like you in some way. It puts human cells on a computer chip that mimic the function of organ systems, thereby possibly reducing the need to test new drugs on animals.

It’s the virtual family—a scary looking group of computer models that scientists can use to see what medical devices would work for their patients.

I especially liked meeting the scientists. Some of them struck me as a bit eccentric, as you might expect. Others are shy and reticent. What they have in common is a genuine commitment to make the world a better place – a safer place.

So the next time that you read the words “regulatory science,” take a second look. The work that goes on under that banner could save your life someday.

Susan Kelly is the managing editor of Consumer Health Information at FDA.

Treating Children with Cancer

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September is National Childhood Cancer Awareness Month. Watch the below video in which two FDA experts discuss existing and new efforts to encourage the development of medicines for kids with cancer.

The conversation is between Robert “Skip” Nelson, M.D., Ph.D., deputy director and senior pediatric ethicist in FDA’s Office of Pediatric Therapeutics, and Gregory Reaman, M.D., associate director of the Office of Hematology and Oncology Products.

It begins with a discussion of FDA’s role in evaluating medications used to treat children with cancer and what measures are underway to encourage further development of these important drugs.

For More Information

Pediatrics

New Pediatric Labeling Information Database

Cancer Liaison Program

Office of Hematology and Oncology Products

FDA Voice interviews Paul C. Howard, Ph.D, on Nanotechnology

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FDA Voice: Thank you for taking time to discuss the exciting field of Nanotechnology with us.  We’ve heard so much about Nanotechnology – what is it exactly and why has it been tagged as the second industrial revolution?

Paul C. Howard, Ph.D., Dr. Howard:  Thank you for the opportunity. It’s been tagged as the “second industrial revolution,” because of its ability and promise to create new materials with new properties.  Decreasing larger-size materials down to sizes in the nano domain may change the properties of these materials. This could have enormous benefits in many arenas. That’s why there is considerable worldwide investment and research for product performance improvement, usefulness, and marketability using nanotechnology. 

Nanotechnology is the science of manipulating materials on a scale so small that they can’t be seen with a regular microscope. The technology could have a broad range of applications, such as increasing the effectiveness of a particular drug, improving the packaging of food, or altering the look and feel of a cosmetic. 

Nanotechnology could also be used in medicines designed for the detection, treatment, and prevention of disease; food production and preservation; water decontamination and purification; environmental remediation; lighter and stronger materials for construction and transportation; and energy resources such as solar cells and fuel-efficiency additives, just to name a few. 

FDA Voice: Is Nanotechnology considered a new field?

Dr. Howard:  Nanomaterials are not new. They have been around as a result of natural and man-made processes for a long time; however, the ability to see and the ability to manipulate matter at the nanoscale are relatively new.

Nanotechnology draws from several science fields like physics, material science, supra-molecular and polymer chemistry, interface and colloidal science, as well as from the chemical, mechanical, biological, and electrical engineering fields.

FDA Voice: If nanotechnology-sized particles are so tiny, how can you actually see them?

Dr. Howard: The best light microscopes you can look through with the human eye get close to seeing materials on the nano scale.  However, to best view nanomaterials, electron microscopes are needed.

Typically, “transmission” electron microscopes – either like an X-ray, where the electrons go through the material – or “scanning” electron microscopes – which bounce electrons off the surface of the object to give stunning three-dimensional images, are used.

Another type of microscope is the atomic force microscope. Fundamentally, it is a bit like an old phonograph, with an arm with a tiny tip on the end (stylus) and it “feels” along the surface.  When it encounters a nanomaterial, or larger, it deflects, giving a measure of its height.

At the National Center for Toxicological Research (NCTR) and the adjacent FDA Office of Regulatory Affairs laboratory, we use all three types of microscopes to image the smallest nanomaterials.

FDA Voice: How does  nanotechnology impact FDA research?

Dr. Howard: Nanotechnology can be used in FDA-regulated products and we are aware that materials that exist in the nanoscale may have unique properties, and thus may warrant examination. 

FDA participates in research programs with collaborating federal agencies to understand the behavior of nanomaterials in biological systems, especially any risk of short- or long-term toxicity.  FDA also collaborates with the National Nanotechnology Initiative (NNI), which serves as the central point of communication, cooperation, and collaboration for all Federal agencies engaged in nanotechnology research.

FDA Voice: Finally, please tell us about the Nanotechnology Core Facility at FDA’s National Center for Toxicological Research.

Dr. Howard: FDA is investing in an FDA-wide nanotechnology regulatory science program that further enhances FDA’s scientific capabilities, including Laboratory Core Facilities, to support regulatory science. 

FDA’s Nanocore facilities are located in Maryland and at FDA’s Jefferson Laboratories just south of Little Rock, Arkansas. The Arkansas Nanocore facility is a joint effort between FDA’s NCTR and Office of Regulatory Affairs’ Arkansas Regional Laboratory. Both facilities are co-located on the Jefferson Laboratories campus.

Nanocore has been designed to support research scientists by providing the equipment and knowledge to characterize nanomaterials. Nanocore also anticipates the needs of scientists by being involved in developing methods to detect nanomaterials in biological samples following the use of nanomaterials in biology experiments. 

Characterization is very important in any science endeavor, especially research where you are trying to understand the relationship between an object and its good or bad properties when it is in a biological system. 

For example, characterization for nanomaterials includes the average size, the aggregation (where they stick together to form a larger mass), shape, chemical composition and purity, surface area, chemistry properties on the surface, chemical/electrical charge on the surface, and stability.  A good description of these is at Characterization Matters,  Nanocore experts work with scientists who need to understand nanomaterial behavior or toxicity and support the work of other scientists who investigate the safety of nanomaterials that may be used in FDA-regulated products. We also characterize the nanomaterials before, during, and after biology or toxicology experiments. Since the equipment and expertise are centralized into this core facility, FDA Nanocore operations also serve as a training resource for FDA regulatory scientists in nanomaterial characterization and detection methods. 

Anyone interested in more on nanotechnology can find a wealth of information on FDA’s website, the U.S. National Nanotechnology Initiative (NNI), and the National Science Foundation.

Paul C. Howard, Ph.D., is the Director of the Office of Scientific Coordination and Director of the Nanotechnology Core Facility at FDA’s National Center for Toxicological Research near Jefferson, Arkansas.