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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...
June 5, 2020

Workshop On Bioanalysis To Be Held By FDA

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...
May 15, 2020

Purple Book Database Of Biological Products Updated By FDA

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...
May 7, 2020

U.S. District Court Issues Temporary Restraining Order for Silver Products Fraudulently Promoted as a Treatment for COVID-19

On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment.  The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19. DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My...
April 17, 2020

FDA Requests Comments On Product User Fee Programs

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an...
March 11, 2020

FTC and FDA Send Warning Letters to Seven Companies about Unsupported Claims that Products Can Treat or Prevent Coronavirus

On March 10, 2020, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19).  The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent...