Guest User
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
Guest User
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
Guest User
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
Guest User
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
Guest User
New Final Guidance Q&A on RRAs

07/08/2025

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In June 2025, The US Food and Drug Administration (FDA) released the final guidance titled; “Conducting Remote Regulatory Assessments Questions and Answers” to facilitate understanding about what a remote regulatory assessment (RRA) is expected from establishments when the FDA initiates or requests an RRA.

New Final Guidance Q&A on RRAs

eLearning

Bye Bye to Five Whys?!

08/16/2022

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Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the Five Whys. But if you have used the Five Whys before, have you noticed that you are not confident in the results?

CRO Oversight Essentials Article Published in Clinical Leader

07/19/2022

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Our article “CRO Oversight Essentials” was recently published in Clinical Leader. Following are some key points.

Oversight does not mean micromanagement. A CRO is contracted for its specific capabilities. It is important to allow the CRO to do whatever it does best and not to overcontrol how they implement.

Trusted Partner Biopharma Institute: Supporting Training for Clinical Trial Management

05/03/2022

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Clinical Pathways has exciting news to share about Biopharma Institute, a trusted partner and reseller for our catalog of eLearning courses. They were featured in Life Sciences Review as a Top 10 Emerging Clinical Trial Management Company of 2022, with an exclusive interview with Sandra “Sam” Sather, VP at Clinical Pathways.