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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

Sandra SAM Sather Speaking at ACRP September 17, 2018 In-Person Event

9/12/2018

SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP)’s September 17, 2018 event. This in-person event will cover tips for managing trials for sites and sponsors post ICH E6 (R2) addendum, and 1.0 ACRP continuing education credits are available.

 

Topic:      Managing Issues that Matter for Sites and Sponsors/CROs Post-GCP E6 (R2)

When:     Monday, September 17, 2018 - 5:30 p.m. – 7:30 p.m. EDT

Where:    Mez Contemporary Mexican (map)

5410 Page Rd.

Durham, NC 27703

Hors d’oeuvres and non-alcoholic beverages provided. Cash bar available.

Register: Registration is through ACRP here