Search
Sharan Murugan
- May 25, 2023
- 2 min
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center...
124 views0 comments
Sharan Murugan
- Dec 27, 2022
- 2 min
ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...
98 views0 comments