The FDA Omnibus Reform Act: 8 Points to Remember

The Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law last year, granting more power to the US Food and Drug Administration (FDA) to perform inspections at home and abroad. Learn more about the bill and 8 points to note in a recent Pharmaceutical Online article by professionals at Greenleaf Health. The first takeaway is that the bill gives many new inspection tools to the agency.

According to Donald D. Ashley and Kala Auchincloss, “FDORA expands FDA’s authority to make mandatory requests to industry for “records and other information” in advance, or in lieu, of an inspection. Section 704(a)(4) of the Food Drug and Cosmetic Act (FDCA) had previously limited use of this authority to drug establishments. Section 3611 of FDORA expands this authority to include device establishments and Section 3612 expands this authority further to bioresearch monitoring (BIMO) sites and facilities.”

To read more, click here.

(Source: Pharmaceutical Online, February 7^th, 2023)