FDA Announces Virtual Public Meeting titled “Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs” - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Announces Virtual Public Meeting titled "Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs"  The Food and Drug Administration is announcing the following public workshop titled "Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs." The purpose of the public workshop is to discuss the challenges and clinical trial design considerations for developing therapeutic products for the treatment of progressive multifocal leukoencephalopathy (PML).   PML is a rare, often fatal, viral disease of the central nervous system that affects patients with immunosuppressive conditions and those treated with immunomodulatory agents. No products are approved for the treatment of PML, and no therapeutic development pathway is established for PML. FDA seeks to discuss scientific and regulatory challenges associated with designing clinical trials evaluating PML treatments, and to develop PML clinical trial designs that are feasible, adequate to establish substantial evidence of effectiveness, adequate to characterize the safety profile of investigational treatments, and acceptable to PML patients, clinicians, regulators, and industry. The agency encourages health care providers, employees of other U.S. Government agencies, academic experts, industry experts, patients and patient advocates, and other stakeholders to attend this public workshop.  Discussions are planned around the following topics areas: Unmet need for PML therapeutics  Key trial design considerations, including feasibility, trial populations, selection of control groups, endpoints, adaptive designs, and master protocols The meeting will take place (in virtual format only) on:   Date: September 21, 2021 Time: 10:00 AM - 4:15 PM ET  Registration for the meeting is now open. Registration is required for online attendance and will be available until midnight on September 20th, 2021. During registration, you may indicate if you wish to present during the virtual public comment session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments.   For more information, please visit the meeting information webpage.    This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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