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Did You Catch the Update to the FDA’s IRB BIMO ...

09/09/2025

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On April 4th, 2025, the U.S. Food and Drug Administration (FDA) updated their Institutional Review Board (IRB) Guidance Manual, part of the Bioresearch Monitoring (BIMO) Compliance Program. Staying up to date with these sorts of regulatory updates will help better prepare for inspections and give IRBs a chance to update any relevant protocols or policies that may not be compliant with these new changes.

Did You Catch the Update to the FDA’s IRB BIMO Manual?
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The Commissioner’s National Priority Voucher ...

08/26/2025

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On June 17th, 2025, the U.S. Food and Drug Administration (FDA) introduced its Commissioner’s National Priority Voucher (CNVP) pilot program to accelerate development of select drugs or biologics from companies that are supporting U.S. national interests and are aligned with U.S. national health priorities.

The Commissioner’s National Priority Voucher Pilot Program
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EMA Releases Guidelines on Inclusion of ...

08/11/2025

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On June 4, 2025 the European Medicines Agency (EMA) posted a guideline titled: ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials. Individuals who are pregnant or breastfeeding make up a significant portion of the world’s population, however, the European Union (EU) reports that less than 0.4% of clinical trials currently submitted to the EU include pregnant people and only 0.1% include lactating individuals. This guideline highlights the importance of including these individuals as well as the steps that should be taken in order to ensure their safety during a trial.  

EMA Releases Guidelines on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
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Inadequate Source Documentation Results in FDA ...

07/29/2025

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On May 29th, 2024, the US Food and Drug Administration (FDA) issued a Form FDA 483 and subsequent warning letter to a Principal Investigator (PI) as the result of objectionable conditions found during an inspection under the Bioresearch Monitoring Program (BIMO).

Inadequate Source Documentation Results in FDA Warning Letter
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Progress Update on the BsUFA III Regulatory ...

07/14/2025

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In January 2025, the US Food and Drug Administration (FDA) posted a progress update video about the third iteration of the Biosimilar User Fee Act (BsUFA III) regulatory science pilot program by sharing results from recent studies, outcomes of round table discussions, and upcoming milestones.

Progress Update on the BsUFA III Regulatory Science Pilot Program

Electronic Informed Consent (eIC): "How The New FDA/OHRP Final Guidance Affects You" - Attend the Feb 22nd WEB Session

2/8/2017

Date: February 22, 2017

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: https://www.lifesciencetraininginstitute.com/doc/electronic-informed-consent-eic-fda-ohrp-final-guidance-training-0001

Description:

An Electronic Informed Consent (eIC) solution needs to be flexible to support very simple to complex projects, as well as from high-risk treatment to non-interventional studies. The newly FDA and OHRP guidance “Use of Electronic Informed Consent – Questions and Answers” reflects the current regulatory thinking on eIC particularly since it is seen as a partner to the paper process instead having to be an either or proposition.

“GCP Renovation” for the Modernization of ICH E8 and Subsequent Renovation of ICH E6! Series Part 1/4

2/6/2017

The International Council for Harmonisation (ICH) is inviting public review and comment on a recently released reflection paper on ICH E6 and ICH E8 renovation and modernization available here. ICH seeks to develop clear guidelines that are “both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources that are being employed to support regulatory and other health policy decisions” while continuing to ensure the human protection and high quality data principles.

Update to ICH GCP E6 (R2) – Final Changes and Implementation – Attend the Feb 15th WEB Session

2/1/2017

The ICH GCP draft is has now been updated and finalized by ICH. Let’s discuss the final content and major implications, how to determine next steps. The update helps end the debate related to many best practices. This impacts sites a great deal and the oversight by sponsor/CROs. Then what about the IRB/IEC?  We will be having a variety of sessions for discussion, training and action planning. To access the guidance, visit the ICH website: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf