Archives

March 6, 2020

FDA Requests Comments On Its Licensed Biological Products Database

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 5, 2020, FDA opened a public docket for comments on its enhancement of the Purple Book, which is otherwise known as FDA’s “Database of FDA-Licensed Biological Products.” As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products...
March 6, 2020

Guidance On Biological Product Transition Issued By FDA

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. Established in 2009, the Biologics Price Competition and Innovation Act (BPCI Act) deemed applications for an approved biological product under Section 505 of the Federal...
March 6, 2020

FDA Announces Educational Initiative To Inform Consumers Of GE Foods

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand genetically engineered (GE) foods. Consisting of science-based information, the initiative’s features include a wide range of resources designed to teach consumers, health care professionals, and students...
February 28, 2020

FDA Upgrades Its Database Of Licensed Biological Products

By Lynn L. Bergeson On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases,...
February 28, 2020

FDA Issues Final Rule Amending The Definition Of “Biological Product”

By Lynn L. Bergeson On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” The new definition incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act). Under the final rule, the statutory term “protein” is interpreted to mean any alpha amino acid polymer with a specific, defined...
February 7, 2020

FDA/FTC To Host Public Workshop On Biosimilars’ Competitive Market

By Lynn L. Bergeson On March 9, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), will host a public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” The focus of the workshop will be on FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, deter anticompetitive behaviors in the biologic marketplace, and discourage false or misleading statements about...
February 3, 2020

NTP Board of Scientific Counselors Will Discuss Human Exposure to Nanoplastics and Microplastics

The National Toxicology Program (NTP) published a Federal Register notice on January 31, 2020, announcing that the Board of Scientific Counselors (BSC) will meet on February 21, 2020.  During the meeting, BSC will review and provide advice on programmatic activities.  According to the preliminary agenda for the meeting, the meeting will include a presentation by Dr. Anil Patri, Food and Drug Administration, National Center for Toxicological Research,...
January 14, 2020

New Joint Website on Agricultural Biotechnology Products Launched by EPA, USDA, and FDA

On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.  This “one-stop-shop” website was created under the direction of Executive Order...
January 10, 2020

USDA, FDA, And EPA Announce Unified Website On Biotechnology

By Lynn L. Bergeson On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO)...
November 22, 2019

FDA Acting Director Of Therapeutic Biologics And Biosimilars Provides Statement On Continued Efforts

By Lynn L. Bergeson On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing...