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.
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
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