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ICH Q3E – Impurities: Extractables and Leachables for Pharmaceuticals and Biologics

On 1 August 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has...

Sharan Murugan

Aug 132 min read

ICH -E21 (USFDA) Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials

In May 2025, the FDA, as part of the International Council for Harmonisation (ICH), endorsed and released for consultation the draft E21...

Sharan Murugan

Jul 273 min read

ICH E20 Draft Guideline: Understanding Adaptive Clinical Trials in Focus (2025)

The International Council for Harmonisation (ICH) has taken a major step toward modernizing clinical trial designs with the release of the...

Sharan Murugan

Jun 283 min read

ICH & USFDA Draft Guidance: Q1 Stability Testing: The Gold Standard for Drug Shelf Life and Quality

The stability of drug substances and drug products is a cornerstone of pharmaceutical quality, ensuring that medicines remain safe,...

Sharan Murugan

Jun 233 min read

ICH Guidance Q1: Stability Testing of Drug Substances and Drug Products (Step 2 Draft 2025)- Public Consultation

The International Council for Harmonisation (ICH) has released a significant update to its stability testing guidelines, consolidating...

Sharan Murugan

Apr 182 min read

Latest ICH Guidance updates: M15-Model-Informed Drug Development, E6(R3)-Good Clinical Practice: Annex 2, & E11A -Pediatric Extrapolation

The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...

Sharan Murugan

Dec 28, 20242 min read

ICH Seeks Market Consultation for Global Post-Approval CMC Assessment Cloud Solution

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a Request for...

Sharan Murugan

Nov 30, 20242 min read

FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers

Yesterday (02 August, 2024), the Food and Drug Administration (FDA) announced that the final guidance on M12 drug interactions was...

Sharan Murugan

Aug 3, 20242 min read

ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

FDA (FDA or Agency) has announced the availability of a draft guidance for the industry called “M14 General Principles on Planning,...

Sharan Murugan

Jul 3, 20242 min read

ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...

Sharan Murugan

May 31, 20242 min read

ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development

Last week the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Office of Regulatory Policy, and the...

Sharan Murugan

Mar 13, 20241 min read

USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities

Earlier today (25 June, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...

Sharan Murugan

Jul 24, 20232 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...

Sharan Murugan

Jun 6, 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...

Sharan Murugan

May 4, 20231 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...

Sharan Murugan

Apr 29, 20232 min read

ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products

In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was...

Sharan Murugan

Mar 1, 20231 min read

ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...

Sharan Murugan

Feb 1, 20231 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...

Sharan Murugan

Dec 27, 20222 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...

Sharan Murugan

Sep 17, 20221 min read

ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation

In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...

Sharan Murugan

Aug 27, 20222 min read