Join us for an engaging and informative Virtual Lunch & Learn series, where we will dive deep into the key aspects of drug development in the U.S. This is the last installment of our 3-part series designed to provide a comprehensive understanding of the critical steps, strategies, and regulatory considerations that drive successful pharmaceutical product development. Whether you’re new to the industry or looking to expand your knowledge, this series will offer valuable insights into the regulatory landscape and the processes that shape the future of medicine.
Part 3 will present the mechanisms that exist to expedite approval of products in the U.S. for the treatment of life-threatening diseases and conditions. The goal of these programs is to accelerate the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternatives. The benefits of each program will be reviewed, and the data requirements for successful application will be discussed.
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