FDA Recommends Development of Guidelines for Nanotechnology
The US Food and Drug Administration's Nanotechnology Task Force (www.fda.gov/nanotechnology/ nano_tf.html) has released a report recommending the agency develop guidelines and take other steps to address the benefits and risks of products, including drugs and medical technology, that use nanotechnology.
The US Food and Drug Administration’s Nanotechnology Task Force (www.fda.gov/nanotechnology/nano_tf.html) has released a report recommending the agency develop guidelines and take other steps to address the benefits and risks of products, including drugs and medical technology, that use nanotechnology. In the report, the Nanotechnology Task Force, which was created in 2006 by FDA Commissioner Andrew von Eschenbach, MD, addresses nanotechnology-associated regulatory and scientific issues, and recommends the FDA create guidance for manufacturers and researchers.
The Task Force reports that nanoscale materials could potentially be used in most product types regulated by the FDA. Nanotechnology presents a particular challenge, however, in that properties relevant to product safety and effectiveness may change as size varies within the nanoscale. The report also states that the uncertain nature and potentially rapid development of nanotechnology highlight the need for creating clear and predictable regulation in this area.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
