Pew Comments on FDA Draft Guidance Documents on Compounded Copies of Approved Drugs

Pew Comments on FDA Draft Guidance Documents on Compounded Copies of Approved Drugs

The Pew Charitable Trusts offered comments on draft guidance documents issued by the Food and Drug Administration in July 2016 regarding compounded drugs that are essentially copies of commercially available or approved drugs. The proposed guidance would preserve the FDA’s approval process, which is critical to protecting patient safety, while allowing important exceptions under limited, specific circumstances, including when a patient has a clinical need for a customized formulation and when FDA-approved drugs are in shortage.

America’s Overdose Crisis
America’s Overdose Crisis

America’s Overdose Crisis

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America’s Overdose Crisis

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37 Scientists Pioneering the Future of Biomedical Research

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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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Learn the Basics of Broadband from Our Limited Series

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How does broadband internet reach our homes, phones, and tablets? What kind of infrastructure connects us all together? What are the major barriers to broadband access for American communities?