BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

Issue link:

Contents of this Issue


Page 3 of 33

4 BioPharm International eBook October 2021 Collecting Industry's Thoughts on FDA FARS Report Industry representatives sound off on FDA's FARS report, released in January this year. I n early 2021, FDA released its Focus Areas of Regulatory Science (FARS) report (1), outlining topics that need con- tinued 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. According to Stephen Hahn, FDA commissioner, FARS is organized across three strategic initiatives that he introduced in 2020: Unleashing the Power of Data, Increasing Choice and Competition through Innovation, and Empowering Patients and Consumers (2). FARS also includes Public Health Emergency Preparedness and Response, which highlights the critical role the agency played in supporting response efforts to the COVID-19 pandemic. INDUSTRY FEEDBACK "The FARS Report is a comprehensive, 55-page document that speaks to the staggering breadth and scope of FDA's regulatory responsibilities to ensure our public health: from food safety, to tobacco, to biologic medicines to vaccines. Far too few are aware to [FDA's] full scope of responsibilities," says Kevin Ott, execu- tive director, Bio-Process Systems Alliance (BPSA). "BPSA lauds the dedication of FDA, and its importance to not just domestic, but also global health concerns and chal- lenges. The FARS report is an important and timely reference document in this regard," Ott adds. Ott also states that the report is intended to identify and communicate priority areas where new or enhanced investments in regulatory science research capacity are essential to support FDA's vast regulatory and public health mission. "Through the fact that FDA supports innovation, partnerships, and informa- FELIZA MIRASOL Regulatory Sourcebook Innovation GORYNVD - STOCK.ADOBE.COM

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - October 2021 - BioPharm-October 2021-Regulatory-Sourcebook