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Finalized Guidance for Industry: Investigator ...

01/08/2026

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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from 2012 and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” from 2009, both of which are now withdrawn.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
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EU Commission Releases Draft Annex 11: ...

12/02/2025

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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
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Warning Letter Issued to Investigator of ...

11/18/2025

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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
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ISO Release DIS 9001:2026 for Quality ...

11/06/2025

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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
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Problems Found in Sponsor-Investigator Led Trial

10/30/2025

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On March 25, 2025 the U.S. Food and Drug Administration (FDA) issued a warning letter to the sponsor-investigator of a study due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection. The sponsor-investigator’s written response to the FDA Form 483 were deemed inadequate therefore the FDA issued a warning letter stating that the sponsor-investigator was noncompliant with multiple regulations within 21 CFR part 312.

Problems Found in Sponsor-Investigator Led Trial

drug development

Finalized Guidance for Industry: Investigator Responsibilities for Safety Reporting

Finalized Guidance for Industry: Investigator Responsibilities for Safety Reporting

01/08/2026

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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.

Upcoming Public FDA Workshop on AI in Drug and Biological Product Development

Upcoming Public FDA Workshop on AI in Drug and Biological Product Development

07/23/2024

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The US Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI) announced an upcoming hybrid public workshop titled “Artificial Intelligence (AI) in Drug & Biological Product Development” on August 6th, 2024 at 10:00am-5:30pm EST. AI refers the area of computer science that creates intelligent machines intended to mirror human cognitive functions such as learning, recognizing patterns and relationships within datasets, adapting, and problem solving. AI is already being put to use in the field of clinical research.

ICH Q9(R1) Quality Risk Management Guidance Adopted

01/24/2023

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The ICH Q9(R1) international guideline on Quality Risk Management reached step 4 on January 18, 2023. Step 4 is when the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulatory Members of the ICH Assembly have adopted the guideline as a harmonized guideline.

How Can Artificial Intelligence Help Clinical Research?

2/05/2020

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The United States Government Accountability Office (GAO) released a report, “Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning in Drug Development.” It outlines six options for policymakers in response to challenges in the use of machine learning in drug development. But why would machine learning be useful in clinical research?