The January 29, 2021, issue of the U.S. Food and Drug Administration’s (FDA) NCTR Research Highlights includes an item highlighting the National Center for Toxicological Research’s (NCTR) nanotechnology-related activities in 2020. The activities include:...
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The Society of Toxicology (SOT) in conjunction with the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide a colloquia series on Emerging Toxicological Science: Challenges in Food and Ingredient Safety. The colloquia will present scientific information that is high-quality, cutting-edge, future-oriented toxicological science and is intended to provide a well-grounded foundation to inform the work of FDA...
Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff. According to the...
November 12, 2020
Explanatory Statement for EPA Appropriations Bill Directs EPA Administrator to Involve FDA in NanoEHS Research
On November 10, 2020, the Senate Committee on Appropriations released 12 fiscal year (FY) 2021 appropriations bills and explanatory statements. The bill for the Department of the Interior, environment, and related agencies includes funding for the U.S. Environmental Protection Agency (EPA). The explanatory statement for the bill includes language regarding nanomaterials research at EPA and states: The Committee notes the increased capabilities that the Food and...
November 6, 2020
FDA Requests Comments On Reauthorization Of BsUFA
By Lynn L. Bergeson On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation...
October 6, 2020
FDA Will Hold NanoDay Virtual Research Symposium on October 9
The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA. The agenda lists the following presentations: Registration is now open....
August 10, 2020
FDA Publishes Report on Nanotechnology — Over a Decade of Progress and Innovation, Will Hold Webinar on August 13
The U.S. Food and Drug Administration (FDA) published a report entitled Nanotechnology — Over a Decade of Progress and Innovation that highlights FDA’s advancements in the field of nanotechnology since it released its last report in 2007. The report also reviews FDA’s role in advancing the public health through its regulation of products within its jurisdiction that involve the application of nanotechnology. According to the report, FDA “will rely on a combination...
August 7, 2020
FDA DHHS Announces 2021 Biosimilar User Fee Rates
By Lynn L. Bergeson On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through...
By Lynn L. Bergeson On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT),the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include: Bioanalytical method...
By Lynn L. Bergeson On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted...