2016 Clinic Manufacturing Screening 
The Medical Futurist
JUNE 21, 2025
In 2016, The Guardian reported that a blind woman suffering from this disease was fitted with the implant labelled “bionic eye” in the UK as part of a trial at the Oxford Eye Hospital. The 80-year-old Ray Flynn lost his central vision entirely, but with the help of the retinal implant, he could make out shapes on the computer screen.
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e., Many sponsors want to reduce animal testing and, therefore, welcome the approach.
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FDA Law Blog
APRIL 7, 2025
Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.
Alabama Academy of Family Physicians
FEBRUARY 20, 2025
Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. Several commercial laboratories are providing this service including Quest, LabCorp, ARUP and Mayo.
FDA Law Blog
NOVEMBER 8, 2022
For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Dr. Baron spoke to specific actions sponsors can take to improve representation of women in cardiac clinical trials.
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