In vivo 3D imaging of human motor units in upper and lower limb muscles.

Objective: To assess in-vivo cross-sectional and 3D morphology of human motor units in hand, forearm and lower leg muscles using magnetic resonance imaging (MRI).

Methods: Diffusion weighted MRI was used with in-scanner electrical stimulation in healthy controls to image motor units at a single slice in lower leg, forearm and hand muscles (n = 6) and multiple slices in the lower leg for 3D assessment (n = 7).

Results: Motor unit cross-sectional area (CSA) and maximum Feret diameter (FD) did not differ between the lower leg (CSA: 22.

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals.

Background: "Patient experience data" (PED) refers to the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients. PED can augment traditional clinical trial data in the FDA's review of product applications. Section 3001 of the 2016 21st Century Cures Act requires the FDA to make a public statement about the PED considered in the approval of a drug application.

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals.

Background: "Patient experience data" (PED) refers to the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients. PED can augment traditional clinical trial data in the FDA's review of product applications. Section 3001 of the 2016 21st Century Cures Act requires the FDA to make a public statement about the PED considered in the approval of a drug application.