Oxford Events, the new replacement for OxTalks, will launch on 16th March. From now until the launch of Oxford Events, new events cannot be published or edited on OxTalks while all existing records are migrated to the new platform. The existing OxTalks site will remain available to view during this period.
From 16th, Oxford Events will launch on a new website: events.ox.ac.uk, and event submissions will resume. You will need a Halo login to submit events. Full details are available on the Staff Gateway.
Over the course of the 20th century, the U.S. Food and Drug Administration was given progressively greater authority to regulate medical products, ultimately requiring pre-approval upon a demonstration of safety and effectiveness. As standards tightened, increased certainty about the clinical benefit of new drugs was paired with inevitably slower access. In response, patients facing serious diseases with unmet treatment needs have pushed for more flexibility, both to access unapproved drugs and for drugs to be approved on weaker evidence. How should regulatory authorities balance the needs – and risk tolerance – of these patients with the need for confidence in drugs allowed on the market?
This lecture will provide a brief history of U.S. drug regulation, describe the pros and cons of pathways (in the U.S. and abroad) that allow early access to drugs whose benefit has not yet been proven, explore what role patient desperation should play in drug approval, discuss potential policy reforms, and identify important questions in need of further research. The U.S. approval of aducanumab for Alzheimer’s disease will be used as a case study, along with other examples.
This will be a hybrid seminar, in-person in the Lower Ground Seminar Room 0, Big Data Institute, University of Oxford, Old Road Campus, Oxford OX3 7LF, or on Zoom. If you will join online, please register at medsci.zoom.us/meeting/register/tJUpdOqrrjkoGdzK168X88chrIu9IvhVgMUu
