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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.
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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.
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On June 5, 2025, the US Food and Drug Administration (FDA) issued a warning letter and FDA Form 483 to an investigator as a result of objectional conditions observed during a Bioresearch Monitoring Program (BIMO) inspection. According to the letter, the investigator did not adhere to the applicable statutory requirements of Title 21 CFR part 312.60 which states: “An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations”.
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In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.
Key Takeaways:
The Special 510(k) Program is an alternate pathway for premarket notifications.
It was originally established in 1998.
It allows manufacturers to declare that a modification to their own device cleared under 510(k) still conforms to design controls.
Currently, if a manufacturer modifies its own marketed device and changes the indication for use or creates technological differences, the application must be submitted as a traditional 510(k).
A new FDA Guidance on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics was released September 25, 2018. As devices become more complex, it becomes more difficult to determine if technological differences mean it is substantially equivalent to a predicate device. The guidance can be found on FDA’s website here.
What: First Ever Metrics Champion Consortium (MCC) Summit
Topic: Clinical Trials Risk and Performance Management Summit. Listen to a panel of subject matter experts present current topics such as metrics, centralized monitoring, critical thinking, and issues and risks management. Our own Sandra “SAM” Sather will present the topics critical thinking and root cause analysis.
When: November 14 and 15, 2018
Where: The Westin Princeton at Forrestal Village; Princeton, NJ map
Book the hotel here
Our own Sandra “SAM” Sather is a contributing author for the HIPAA Privacy Rule and FDA Regulated Clinical Trials chapter, which extensively answers questions about protection of privacy during clinical research. The reference guide answers more than 1000 common questions related to US and international Good Clinical Practice (GCP) for clinical trials.
