Archives

August 27, 2010

FDA Will Hold Public Workshop on Medical Devices and Nanotechnology

On 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 on these topics and...
July 26, 2010

Safe Cosmetics Act Would Allow FDA to Require Labeling of Nanomaterials

On 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: Regarding cosmetic and ingredient statements, the bill would require manufacturers to submit electronically a statement containing certain information, including “the ingredient list as it...
June 9, 2010

FDA Posts MAPP on Reporting Format for Nanotechnology-Related Information

On 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 within OPS with the framework by which relevant information about nanomaterial-containing drugs will now be...
March 12, 2010

FDA Responds to EWG’s Letter Concerning Sunscreen Guidelines

In 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 FDA to publish a final rule for its August 2007 draft sunscreen...
March 11, 2010

American Academy of Dermatology Annual Meeting Includes Presentation on Nanotechnology in Cosmetic Products

During 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 the potential to enhance sunscreens, shampoos, conditioners, lipsticks, eye shadows, moisturizers, deodorants, after-shave...
June 24, 2009

FDA Spokesperson Says Regulatory Authority Is Sufficient to Address Nanotechnology

According 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 the FDA seeking acceptance of a nanotech food additive or coloring should address its “impact on identity and...
May 1, 2009

PEN Report on Oversight of Next Generation Nanotechnology Recommends New Federal Agency

On 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 Davies, Ph.D., the agency would be primarily a scientific agency with a strong...
March 18, 2009

FDA Assessing Feasibility of Using Nanotechnology Test to Detect Anthrax Following a Bioterrorist Attack

On 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 europium nanoparticle-based immunoassay (ENIA) was able to detect the presence of a protein made by the...
March 12, 2009

FDA Announces Nanotechnology Collaboration

On 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 the knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and...
March 4, 2009

FDA Panel States FDA Wants More Information before Issuing Guidance

During 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 so that FDA can learn more about the effects of nanotechnology. Sackner-Bernstein acknowledged that the...