The FDA has released a final guidance document intended to help industry members develop bioanalytical methods and validations that are required by the FDA to ensure the quality of an assay and the reliability of the data it generates.
The FDA has released a final guidance document intended to help industry members develop bioanalytical methods and validations that are required by the FDA to ensure the quality of an assay and the reliability of the data it generates.
The guidance incorporates public comments to the revised draft guidance that was first published in 2013. It also provides recommendations for the development, validation, and in-study use of bioanalytical methods.
The guidance indicates that its recommendations can be modified with justification, depending on the specific type of bioanalytical method.
In order to validate the analytical method used to evaluate analytes (for example, drugs, including biologics, and their metabolites), the FDA recommends that if the data address the following key questions, they are reliable:
Additionally, the final guidance incorporates a new title for Section 3, “Bioanalytical Method Development and Validation,” as well as new sections about the bioanalytical parameters that apply to chromatographic assays and ligand binding assays.
Specifically, the guidance has included the latest scientific practices in method validation, newer science on incurred sample reanalysis, the use of new analytical platform, the repurposing of diagnostic kits for drug development, and validation for biomarkers in drug development.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability
June 20th 2024The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.
British Columbia’s Biosimilar Switching Program Saves $732 Million in 5 Years
June 18th 2024British Columbia's 2019 Biosimilars Initiative, which transitioned over 40,000 patients from costly reference biologics to biosimilars, saved around $732 million in 5 years, maintained comparable health outcomes, and reinvested the savings to improve the province's public payer program.