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

10/08/2025

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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?
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The EU’s CTR and CTIS is Now in Full Effect

09/22/2025

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On January 31st, 2025, the European Medicines Agency (EMA) reached another major milestone for the implementation of the Clinical Trials Regulation (CTR), the European Union’s (EU) current pharmaceutical legislation. The CTR has updated the many of the CTD policies; promoting communication between trials and regulators, increased transparency between trials and the public, and reducing financial and administrative burdens.   

The EU’s CTR and CTIS is Now in Full Effect
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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

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