New FDA Tools for Investigators and Clinicians
June 4, 2021
The FDA recently released two new tools that were developed for investigators and clinicians: 1) Research IND Pilot Portal and 2) Expanded Access eRequest.
Tag: FDA
NIH and FDA Seek Feedback on Clinical Trial Protocol Template
March 31, 2016
I’d like to call your attention to an opportunity to provide comments on a proposed clinical trial protocol template, developed by the FDA and NIH, and informed by the guidance set forth by the International Conference on Harmonisation (ICH) E6 Good Clinical Practice. The template provides a standard format, and corresponding instructions and sample text, for…
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