2018 Clinic Manufacturing Specialization 
The Medical Futurist
JUNE 21, 2025
Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. The Stanford Artificial Retina Project shows great promises.
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 FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e., In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,
FDA Law Blog
OCTOBER 25, 2021
It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. The new rule will be codified in 21 C.F.R. Part 860.
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