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Jun 6, 20231 min read

USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials

The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...

May 4, 20231 min read

ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management

Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

Apr 29, 20232 min read

ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products

On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...

Dec 27, 20222 min read

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Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...

Sep 17, 20221 min read

ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES

Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the...