Archives

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FDA Announces Availability Of Draft Guidance On Bioequivalency For Soluble Powder Oral Dosage Form P

By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from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...
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...
June 25, 2019

Registration Opens for NNI Webinar on Nanotechnology-Related Standards

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...
May 24, 2019

HHS Announces Availability Of Draft Guidance On Therapeutic Protein Biosimilars

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...
May 17, 2019

FDA Issues In Final Guidance On Interchangeable Biosimilars

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...
May 10, 2019

FDLI Conference On Drug, Biologics, And Biosimilars Law And Regulation

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...
May 3, 2019

EPA Corrects 200 ppb Level Description in Technical Amendment to Data Requirements for Antimicrobial Pesticides Final Rule

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...