💊FDA Guidance on Formal Meetings for Biosimilar Products
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products." This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of proposed biosimilar, including interchangeable biosimilar, products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title issued on August 11, 2023.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory notice outlines formal meeting guidelines between the FDA and biosimilar applicants, providing clarity on compliance and procedures. This impacts business owners in the pharmaceutical sector by defining expectations regarding communication and documentation for biosimilars, which could affect development timelines and costs.