Well-designed clinical trials are the cornerstone of how we develop medicines and are critical to the understanding of the safety and efficacy of new medicines. DBV’s investigational products have not yet received health or regulatory approval in any country and are available through participation in ongoing clinical trials.
In some limited circumstances, investigational products may be available through DBV’s Expanded Access Program.
Expanded access, also commonly referred to as “compassionate use”, may be an option for individuals who meet certain criteria, including those described in the section General Eligibility Criteria below.
It’s important to remember that since DBV’s investigational products have not yet received health or regulatory approval, the potential risks and benefits are not yet established. Healthcare providers and patients should consider all possible benefits and risks when seeking expanded access of an unapproved product.
All requests for expanded access must be made by a treating physician on behalf of the child and the child’s parent or adult guardian. The physician may submit questions or requests regarding expanded access to firstname.lastname@example.org or by speaking with an Early Access Coordinator at 203-441-7939. All requests will be acknowledged within one business day. Please note, not all expanded access requests may be granted.
Physicians must follow local laws and regulations appropriate for the country originating the request.
In the U.S., physicians may find additional information on expanded access by visiting the U.S. Food and Drug Administration website Expanded Access: Information for Physicians.
Physicians in Canada must follow regulations specific to Canada, by following the procedure found here for Special Access Request.
In addition to other obligations for safety reporting as required by federal regulations a written description of any serious adverse event (SAE), using the SAE reporting form, must be submitted to DBV Technologies within 24 hours after becoming aware of the event. Please submit SAE to: email@example.com
DBV Technology has made this information available in support of the 21st Century Cures Act, including 561A to the Federal Food, Drug, and Cosmetic Act (FD&C Act).