Guest User
FDA Releases Final Guidance on ICH E6(R3)

02/03/2026

-

On September 8th, 2025, the US Food and Drug Administration (FDA) released their final guidance for industry on the ICH E6(R3) Good Clinical Practice (GCP). ICH E6(R3) Principles and Annex 1 were finalized on January 6th, 2025, officially taking over the preceding 2016 ICH E6(R2). Annex 2 is expected to be finalized in early 2026.

FDA Releases Final Guidance on ICH E6(R3)
Guest User
Finalized Guidance for Industry: Investigator ...

01/08/2026

-

On December 15th, 2025, the US Food and Drug Administration (FDA) released the finalized guidance for industry “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices”. Unlike most updates, this finalized guidance is replacing the FDA’s recommendations from two separate final guidance documents: “Safety Reporting Requirements for INDs and BA/BE Studies” from 2012 and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” from 2009, both of which are now withdrawn.

Finalized Guidance for Industry: Investigator Responsibilities for Safety Reporting
Guest User
EU Commission Releases Draft Annex 11: ...

12/02/2025

-

On July 7, 2025, the European Union (EU) Commission and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published an updated draft of Annex 11: Computerised Systems, a supplementary guideline that is part of the Good Manufacturing Practice (GMP). Although it is GMP focused, the guiding principles of the annex can also be applied to other GxP standards.

EU Commission Releases Draft Annex 11: Computerised Systems
Guest User
Warning Letter Issued to Investigator of ...

11/18/2025

-

In July, 2025, the US Food and Drug Administration (FDA) issued a warning letter to an investigator conducting a clinical trial for pediatric participants. The warning letter was the result of a routine inspection part of the FDA’s Bioresearch Monitoring Program (BIMO) as well as the investigator’s written response to the Form FDA 483.

Warning Letter Issued to Investigator of Pediatric Study
Guest User
ISO Release DIS 9001:2026 for Quality ...

11/06/2025

-

On August 27, 2025, the International Organization for Standardization (ISO) released a Draft International Standard (DIS) for the ISO 9001:2026 Quality Management Systems (QMS) to ISO member bodies for a twelve-week review and ballot period. The goal of ISO 9001 is to help organizations create and maintain consistency of their products or services and seeks to improve and refine their internal processes and procedures to increase efficiency.

ISO Release DIS 9001:2026 for Quality Management Systems

Additional Delay in Timing of the Compliance to the Updates to the Common Rule. This is Your Opportunity to comment on changes!

4/23/2018

The US Department of Health and Human Services along with 16 other agencies published a Notice of Proposed Rulemaking (NPRM) to delay the compliance date of the updated “Federal Policy for the Protection of Human Subjects,” also known as the “Common Rule,” published in the Federal Register on January 19, 2017. The January 2017 final rule is also known as the “2018 Requirements.”

Sandra SAM Sather Speaking at April 2018 ACRP Conference

4/16/2018

SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP)’s April 2018 Expo. The session will cover global regulatory issues and counts as 1.0 ACRP continuing education credits.

 

Topic:        “A Global Perspective on Regulations Impacting Clinical Research”

When:        Monday, April 30, 2018 - 3:00 p.m. – 4:00 p.m. EDT

Where:       Gaylord National Resort & Convention Center - National Harbor, Maryland (map)

FDA's Patient-Focused Drug Development – Part 2

4/12/2018

In part 1 of our FDA's Patient-Focused Drug Development blog, we discussed the origin of FDA’s patient-focused drug development from Prescription Drug User Fee Act (PDUFA) V and VI and the 21st Century Cures Act (Cures Act) to the development of a guidance that will allow for the direct collection of patient experience data to guide regulatory decision-making. Plan for Issuance of Patient‐Focused Drug Development Guidance from May 2017 describes FDA’s plan for development of a guidance under the Cures Act.