Pew Comments on FDA Guidance Document Concerning Biological Products

The Pew Charitable Trusts offered comments on a revised draft guidance document issued by the Food and Drug Administration in January 2017, which would allow certain manipulations of commercial biological products outside of the labeling instructions in order to meet a clinical need. The revised proposal improves upon an early draft by creating an option for compounders that comply with high quality standards to set longer beyond-use dates supported by testing, which strikes a reasonable balance between the practical advantages of extended dating and the need to ensure product sterility.