Register NowFDA FSMA Food Defense Plan Requirements Wednesday, July 24, 20191:00 p.m. - 2:00 p.m. (EDT) Overview:The U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) is the most comprehensive reform measure created to prevent food-borne illness. Enacted in 2011, FSMA includes massive legislative changes aimed to prevent food-borne diseases. One of the FSMA foundational rules, Mitigation Strategies to Protect against Intentional Adulteration, requires...
Category: FDA
Registration has opened for the National Nanotechnology Initiative’s (NNI) July 9, 2019, webinar, “Nanotechnology-Related Standards: Availability and Applications.” According to NNI, the development and use of nanotechnology-related standards is critical to ensuring validated measurements and methods to specify nanomaterial-containing products. NNI states that standards are also necessary for comparative evaluation and assessment of the environmental, health, and...
Wednesday, July 24, 20191:00 p.m. - 2:00 p.m. (EDT) View this webinar on demand online. Overview: The U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) is the most comprehensive reform measure created to prevent food-borne illness. Enacted in 2011, FSMA includes massive legislative changes aimed to prevent food-borne diseases. One of the FSMA foundational rules, Mitigation Strategies to Protect against Intentional Adulteration, requires...
June 7, 2019
APHIS Proposes Revised Regulatory Framework Regarding the Movement of Certain Genetically Engineered Organisms
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms. 84 Fed. Reg. 26514. The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk...
May 31, 2019
OECD Tour de Table Provides Updates on Developments on the Safety of Manufactured Nanomaterials
As reported in our May 30, 2019, blog item, the Organization for Economic Cooperation and Development (OECD) recently published several reports in its Series on the Safety of Manufactured Nanomaterials, including Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 19th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in February...
By Lynn L. Bergeson On May 22, 2019, the U.S. Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a...
Preserving Cosmetics on a Global Scale: It is Harder than You Think Wednesday, May 22, 2019 1:00 p.m. - 2:00 p.m. (EDT) Register Today Overview: Cosmetic formulations often contain preservatives to protect the product’s integrity and extend its shelf life. The regulatory requirements that product manufacturers must adhere to when incorporating preservatives into their products and what claims are permissible on their product labels is far from harmonized globally, and the path is not getting...
By Lynn L. Bergeson On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be...
By Lynn L. Bergeson From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of marketing...
On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W. 84 Fed. Reg. 18993. The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and...