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© 2022 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
March 07, 2018
The FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.
February 12, 2018
The FDA's new draft IVD Guidelines will need to be factored into how pharma clinical trial sponsors use IVDs in a clinical trial, study design, timeline for protocol development, IND submission, and study initiation.