All Knowledge & Insights By Date

Click here for a PDF brochure of the memorandum, and click here to listen to the special Forecast 2020 edition of the All Things Chemical podcast. Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2020. In this detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our...

On December 4, 2019, the U.S. Environmental Protection Agency (EPA) published an advance notice of proposed rulemaking (ANPRM) soliciting information as EPA considers a future rulemaking to add certain per- and polyfluoroalkyl substances (PFAS) to the list of toxic chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and Section 6607 of the Pollution Prevention Act (PPA) (more commonly known as the Toxics Release Inventory...

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...

By Lynn L. Bergeson On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical...

We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.”  Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of...

By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo...

By Lynn L. Bergeson On August 19, 2019, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that a proposed collection of information on the Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act has been submitted to the Office of Management and Budget (OMB) for review and approval. This information collection supports the review program under the Prescription Drug User Fee Act (PDUFA), which allows FDA to...

By Lynn L. Bergeson On August 2, 2019, the U.S. Department of Health and Human Services (HHS)’s Food and Drug Administration (FDA) announced via the Federal Register the rates for biosimilar user fees for FY 2020. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar...

PlasticsToday, “A Visual Tour of Packaging and Products from Ocean Plastics” geek.com, “Scientist Creates Bioplastic from Mango Peels and Seaweed” foodingredientsfirst.com, “European Scientists Call for EU Rethink of ‘Retrograde’ Gene-Editing Legislation” New Atlas, “Wormy Chemicals Used to Trick Crops into Protecting Themselves” Regulatory Focus, “Industry Groups Support FDA’s Latest Biosimilar Analytic Assessment...

Bergeson & Campbell, P.C. (B&C®) was pleased to present the complimentary webinar “FDA FSMA Food Defense Plan Requirements.” Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, presented.

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...

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...

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...

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...