Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more
A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more