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...
Category: FDA
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...
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...
October 11, 2019
FDA Publishes Technical Specifications Guidance For Bioanalytical Methods Templates
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...
October 4, 2019
Lynn L. Bergeson and Carla N. Hutton Co-Author Article on Nanotechnology and Regulatory Certainty
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...
October 4, 2019
FDA Announces Availability Of Draft Guidance On Bioequivalency For Soluble Powder Oral Dosage Form P
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...
August 23, 2019
FDA Announces Collection Of Information Submission To OMB
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...
August 16, 2019
FDA Announces Biosimilar User Fee Rates For FY 2020
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...
August 9, 2019
Weekly Roundup of Other Biobased News
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...
July 24, 2019
WEBINAR—FDA FSMA Food Defense Plan Requirements, July 24, 2019, 1:00 p.m. – 2:00 p.m. EDT
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.