By Lynn L. Bergeson and Carla N. Hutton on Posted in Federal,Legal/Regulatory Issues,United StatesOn December 18, 2017, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials: Guidance for Industry.” According to the notice, FDA developed the guidance to provide industry with its current thinking for the development of… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in Federal,Legal/Regulatory Issues,United StatesThe Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in Federal,Legal/Regulatory Issues,United StatesThe Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in Federal,Legal/Regulatory Issues,United StatesOn August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled “Guidance for Industry: Use of Nanomaterials in Food for Animals.” The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that… Continue Reading
By Lynn L. Bergeson on Posted in Federal,International,Legal/Regulatory Issues,United StatesA coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the U.S. District Court for the Northern District of California on December 21, 2011. The coalition is led by the International Center for Technology Assessment (ICTA), and includes Friends of the Earth, Food and Water Watch, the Center… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,ResearchOn October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesThe U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities. FDA notes that rapid advances in innovative science have provided new technologies to discover,… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesThe Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, “despite myriad uncertainties about the public health and environmental effects of ENMs.” According to the report, several steps… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Research,United StatesIn a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science. NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000. According to the press… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn September 23, 2010, the Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA is seeking input… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) “to ensure the safe use of cosmetics.” Under the bill, the Secretary of the Food and Drug Administration (FDA) would: Monitor developments in the scientific understanding of any… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,Research,United StatesOn June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesIn a March 2, 2010 letter, the Food and Drug Administration (FDA) responded to the Environmental Working Group’s (EWG) July 15, 2009, letter concerning sunscreen guidelines. EWG criticized the FDA for not having guidelines for sunscreen safety and efficacy. According to EWG, companies continue to profit by misleading consumers about the protection offered by their products. EWG urged… Continue Reading
By Lynn L. Bergeson on Posted in Legal/Regulatory Issues,Research,United StatesDuring the 68th annual meeting of the American Academy of Dermatology, on March 4, 2010, dermatologist Adnan Nasir, M.D., Ph.D., F.A.A.D., gave a presentation on nanotechnology and how nanoparticles may eventually be used in cosmetic products. According to Dr. Nasir, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesAccording to a June 8, 2009, article, Dr. Annette McCarthy of the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition stated on June 6, 2009, at the Institute of Food Technologists’ annual meeting that the “regulatory authority is sufficient to address nanotechnology but there are further questions.” McCarthy recommended that petitions to… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn April 28, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Oversight of Next Generation Nanotechnology, which calls for the creation of the Department of Environmental and Consumer Protection, which would oversee product regulation, pollution control and monitoring, and technology assessment. According to report author J. Clarence… Continue Reading
By Lynn L. Bergeson on Posted in Federal,United StatesOn March 17, 2009, the U.S. Food and Drug Administration (FDA) announced that it has completed a “proof-of-concept” study of a test that “quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin.” According to FDA, the proof-of-concept study relies on a nanotechnology-based test platform built from tiny molecular-sized particles. The… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn March 10, 2009, the Food and Drug Administration (FDA) announced a collaboration with the Alliance for NanoHealth (ANH) and its members. According to FDA, the collaboration is intended to “help speed development of safe and effective medical products in the emerging field of nanotechnology.” Under a memorandum of understanding, FDA and ANH will work to increase… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,Research,United StatesDuring the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn January 14, 2009, the Project on Emerging Nanotechnologies (PEN) released a report entitled A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, which describes problems at the Food and Drug Administration (FDA) in regulating nano-enabled dietary supplements and offers recommendations for improving oversight. According to the report, FDA’s ability to regulate… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn October 30, 2008, Consumers Union petitioned the Food and Drug Administration (FDA) to require a full safety assessment on the use of engineered nanoparticles, particularly in cosmetics, sunscreens, and sunblocks, and “to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.” Consumers Union cites new findings in the… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesThe United States Food and Drug Administration (FDA) held its publicized Public Meeting on Nanotechnology on Monday, September 8, 2008, near its main offices in Rockville, Maryland. The meeting consisted of a plenary session led by Dr. Norris Alderson, Co-Chair of the FDA Nanotechnology Task Force, followed by separate breakout sessions for prescription and over-the-counter (OTC)… Continue Reading
