Pew Comments on FDA Guidance Document Concerning Biological Products

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Projects: Drug Safety
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The Pew Charitable Trusts offered comments on a revised draft guidance document issued by the Food and Drug Administration in January 2017, which would allow certain manipulations of commercial biological products outside of the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.

Downloads Pew Comments on FDA Guidance Document Concerning Biological Products (PDF)

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Downloads Pew Comments on FDA Guidance Document Concerning Biological Products (PDF)
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Biomedical researchers are at the heart of nearly every medical advancement. From cutting-edge cancer treatments to breakthrough discoveries about emerging viruses, these scientists use creativity and ingenuity to explore new horizons in human health and medicine. And for nearly 40 years, The Pew Charitable Trusts has supported more than 1,000 early-career researchers committed to this work.

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