Apr 21, 2022 | Federal Issues
By Surabhi Dangi-Garimella, PhD Diversity presents facts. Diversity provides a true reflection of reality, and this holds true for clinical trials as well. The FDA’s Office of Minority Health and Health Equity is a big proponent of diversity among clinical trial...
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Mar 21, 2022 | Federal Issues
By Surabhi Dangi-Garimella, PhD User fee agreements—whether for a medical device or a prescription drug—create a path for manufacturers to get their product reviewed in a systematic manner by the FDA. The Medical Device User Fee and Modernization Act of 2002, known as...
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Feb 28, 2022 | Featured, Federal Issues
On this episode of the podcast, Terry and Bob discuss accelerated drug review for rare diseases. This topic coincides with Rare Disease Day on February 28. With the Prescription Drug User Fee Act (PDUFA) up for renewal in Congress, much is at stake for the rare...
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Feb 24, 2022 | Featured, Federal Issues
By Surabhi Dangi-Garimella, PhD The 21st Century Cures Act is being rekindled: introduced in Congress in November 2021, CURES 2.0 proposes to upgrade several areas of the U.S. healthcare system, one of which is telehealth. The Telehealth Modernization Act includes...
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Feb 8, 2022 | Federal Issues
By Surabhi Dangi-Garimella, Ph.D. Advanced Research Projects Agency for Health (ARPA-H)—that’s the name of the new $6.5 billion agency being proposed as part of the next iteration of the 21st Century Cures Act (CURES 2.0). Along with an infusion of funding into the...
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Jan 31, 2022 | Federal Issues, Health Policy
By Surabhi Dangi-Garimella, Ph.D. Repair restrictions by equipment manufacturers remains a significant issue that spans industries and is relevant to consumer protection and antitrust issues related to repair restrictions—be it phone or car manufacturers or...
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