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Krista Carver

Krista Hessler Carver advises medical device, biotechnology, pharmaceutical and cosmetic manufacturers and trade associations on a wide range of FDA regulatory, compliance, transactional, and legislative matters. Ms. Carver has particular experience with legal and regulatory issues related to biosimilars, medical devices, combination products, and personalized medicine.

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FDA Announces Public Workshop on Using Randomized Clinical Trials to Generate Real-World Evidence

By Mingham Ji, Wade Ackerman and Krista Carver on Posted in EHR/EMR, Health Data
Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.”  This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post. According to … Continue Reading

Key Takeaways from FDA’s Framework for Real-World Evidence for Pharmaceuticals

By Mingham Ji, Wade Ackerman, Krista Carver, Nigel Howard and Denise Esposito on Posted in Artificial Intelligence (AI), Health Data, Innovation, Medical Apps
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”).  In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top … Continue Reading

Significant FDA Digital Health Policy Development for Prescription Drug Sponsors

By Mingham Ji, Christina Kuhn, Elizabeth Guo, Wade Ackerman and Krista Carver on Posted in Artificial Intelligence (AI), Medical Apps, Medical Devices and FDA
As previewed by Commissioner Gottlieb several months ago (see our earlier post here), FDA published a notice in the Federal Register on November 20, 2018, to propose a new framework for “prescription drug-use-related software.” The Agency defines this digital health category widely as software disseminated by a prescription drug sponsor for use with the sponsor’s … Continue Reading
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