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

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

09/22/2025

-

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.   

Did You Catch the Update to the FDA’s IRB BIMO Manual?

Did You Catch the Update to the FDA’s IRB BIMO Manual?

09/09/2025

-

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.

The Commissioner’s National Priority Voucher Pilot Program

The Commissioner’s National Priority Voucher Pilot Program

08/26/2025

-

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.

EMA Releases Guidelines on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

EMA Releases Guidelines on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

08/11/2025

-

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.  

Inadequate Source Documentation Results in FDA Warning Letter

Inadequate Source Documentation Results in FDA Warning Letter

07/29/2025

-

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).