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
Guest User
Problems Found in Sponsor-Investigator Led Trial

10/30/2025

-

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
Guest User
Sponsor BIMO Warning Letter – What is a Drug?

10/08/2025

-

On April 30th, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter and Form FDA 483 to the sponsor of a clinical investigation as the result of a Bioresearch Monitoring Program (BIMO) inspection. 40 participants were enrolled in the study and took the investigational product that the sponsor claims was to help individuals with sleeping disorders without submitting an Investigational New Drug (IND) application.

Sponsor BIMO Warning Letter – What is a Drug?

Computer Modeling and Simulations for Device Regulatory Submissions Draft Guidance

01/11/2022

-

The US Food and Drug Administration (FDA) released a draft guidance, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” late December 2021. The draft guidance provides a framework for assessing if software modeling used to support medical device premarket submissions are credible. Regulatory submissions often lack adequate explanation of the rationale for the models’ credibility for the context of use (COU). The COU is the specific role and scope of the model used to address the “question of interest.”

Device Software Functions Draft Guidance: Comment Now!

01/04/2022

-

The US Food and Drug Administration (FDA) released a draft guidance “Content of Premarket Submissions for Device Software Functions.” The draft guidance clarifies documentation that is needed for a premarket submission for device software functions. The 21st Century Cures Act excluded certain software functions from the definition of device (see the guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”). The draft guidance addresses these changes as well as the evolution of digital health and the recent FDA recognized consensus standards for software, which are standards that the FDA determines can support clearance or approval of a device.

Live Virtual Train-The-Trainer: Risk Assessment & Issues Management with the DIGR-ACT® Critical Thinking Solution

12/20/2021

-

This workshop is for GXP professionals who are interested in adapting or adopting DIGR-ACT® into their operations to better support critical to quality factors and their quality system and how to train their teams in the DIGR-ACT® process.

Dates: Two part series (6 hours total) – Online live attendance mandatory

15 February 2022, 10:00 AM to 1:00 PM (EST)

AND

22 February 2022, 10:00 AM to 1:00 PM (EST)

Location: Live online

Registration: HERE

Comment Now! Draft Guidance: Using RWE to Support Clinical Trials and Observational Studies

12/14/2021

-

The US Food and Drug Administration (FDA) released a draft guidance “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products” for public comment in December 2021. This draft guidance is published as part of a series of real-world evidence (RWE) guidance in line with the 21st Century Cures Act (Cures Act). Part of the Cures Act is related to the use of real-world evidence (RWE) to help support regulatory decision making, including the approval of a new indication for an approved drug or to support post approval study requirements. This draft guidance discusses its applicability in using RWE in clinical trials and observational studies.

Comment Now! Another RWE Draft Guidance: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products

12/07/2021

-

The US Food and Drug Administration (FDA) released a draft guidance “Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products” for public comment in November 2021. This draft guidance is published in line with the 21st Century Cures Act (Cures Act). A good source of RWE, a registry is an “organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or exposure.”