Amendments to Sterility Test Requirements for Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition‪)‬

The Law Library presents the complete text of the Amendments to Sterility Test Requirements for Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018

The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.

This ebook contains:
- The complete text of the Amendments to Sterility Test Requirements for Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure