Newsletter - April 25, 2019
FDA’s Approval of a Novel ADHD Devices Sheds Light on Regulatory Process
Last week FDA approved a unique device for the treatment of ADHD in 7-12-year-old children. The process followed for the approval of this first-of-its-kind device highlights the lengths to which FDA may go to approve new devices with unique technologies that can be a useful lesson to other developers of products that meet similar conditions. Read More
Peer-Reviewed Publications by FDA and Other Government Agencies
The USDA recently enacted an internal policy that all peer-reviewed publications authored by its scientists carry a disclaimer that it represents “preliminary” findings. While this policy seems to be limited to USDA only, but it was not publicized and there is no way to know if similar policies exist at other government agencies such as FDA. Read More
FDA’s Approval of a Novel ADHD Devices Sheds Light on Regulatory Process
Last week FDA approved a unique device for the treatment of ADHD in 7-12-year-old children. The process followed for the approval of this first-of-its-kind device highlights the lengths to which FDA may go to approve new devices with unique technologies that can be a useful lesson to other developers of products that meet similar conditions. Read More
Peer-Reviewed Publications by FDA and Other Government Agencies
The USDA recently enacted an internal policy that all peer-reviewed publications authored by its scientists carry a disclaimer that it represents “preliminary” findings. While this policy seems to be limited to USDA only, but it was not publicized and there is no way to know if similar policies exist at other government agencies such as FDA. Read More
