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Collecting Industry’s Thoughts on FDA FARS Report
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Collecting Industry’s Thoughts on FDA FARS Report
Publication
Article
BioPharm InternationalBioPharm International, Regulatory Sourcebook October 2021
Volume 2021 eBook
Issue 4
Pages: 4–5
Industry representatives sound off on FDA’s FARS report, released in January this year.
gorynvd/Stock.adobe.com
FDA’s January 2021 release of its Focus Areas of Regulatory Science (FARS) report outlines topics that need continued targeted investment to advance regulatory science research that can facilitate the development of innovative products. The report also outlines the agency’s needs for data provision and methodology clarification to inform its regulatory decision-making process in the hopes that this will improve guidance for sponsors. Representatives from Bio-Process Systems Alliance and BioPhorum shared their thoughts on the report and provided feedback from an industry perspective.
Read this article in BioPharm International’s October 2021 Regulatory Sourcebook eBook.
About the author
Feliza Mirasol is the science editor for BioPharm International.
Article Details
BioPharm International
eBook: Regulatory Sourcebook, October 2021
October 2021
Pages: 4–5
Citation
When referring to this article, please cite it as F. Mirasol, “Collecting Industry’s Thoughts on FDA FARS Report," BioPharm International Regulatory Sourcebook eBook (October 2021).
Articles in this issue
Industry Organizations Assist Pharma During the Pandemic and Beyond
NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations
How Artificial Intelligence Impacts the Global Regulatory Environment
Selecting the Right CMC Strategy for Biologics
The Evolving Biosimilar Approach
Serialization and Aggregation from a Manufacturing Perspective
The Real Danger of Substandard and Counterfeit COVID-19 Vaccines
Collecting Industry’s Thoughts on FDA FARS Report
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