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Josh suggests that within the results section of your application you should keep in mind that explaining how you came to the conclusion of your results will save the FDA reviewer critical time.
December 21, 2021
FDA reviewers spend massive amounts of time answering three common (internal) questions — What was supposed to be done during the clinical trial, what was actually done during the clinical trial, and are these same thing? (ie are they being consistent).
December 15, 2021
Immunicom Hires Former FDA Clinician and Medical Device Reviewer to Rapidly Progress Launch of Novel Cancer Immunotherapy.
December 13, 2021
We'll have another one coming up shortly to your, FDA Friday, it's been fun to interview former FDA reviewers and just see.
December 08, 2021
It may also be interesting to note that some of his strategies and tips can now be supplemented with the latest technologies such as virtual workspaces in order to allow the Sponsors and CRO’s to more effectively process, collaborate on, and ultimately present their study data to the FDA reviewers.
December 07, 2021