Newsletter - August 25, 2022
FDA Clarifies Rules for Charging Patients to Participate in Your Clinical Trial
Clinical trial sponsors with limited resources are permitted to charge patients for participating in their trial. However, there are rules and strict limitations for the cost that can be recovered from patients, and FDA’s permission must be obtained prior to charging patients. Sponsors have been allowed to charge the cost of manufacturing...Read More
FDA Eases Exporting Unapproved Medical Devices Using Self-Certified Letters
Medical devices not approved for sale in the US can be exported to other countries provided FDA determines that such exportation is not contrary to the public health and safety, and the device has the approval of the foreign country to which it is being exported. The manufacturers of such devices need to obtain...Read More
FDA Clarifies Rules for Charging Patients to Participate in Your Clinical Trial
Clinical trial sponsors with limited resources are permitted to charge patients for participating in their trial. However, there are rules and strict limitations for the cost that can be recovered from patients, and FDA’s permission must be obtained prior to charging patients. Sponsors have been allowed to charge the cost of manufacturing...Read More
FDA Eases Exporting Unapproved Medical Devices Using Self-Certified Letters
Medical devices not approved for sale in the US can be exported to other countries provided FDA determines that such exportation is not contrary to the public health and safety, and the device has the approval of the foreign country to which it is being exported. The manufacturers of such devices need to obtain...Read More
