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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.
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Topic: Critical Thinking in Clinical Research and DIGR-ACT®
Date: May 7, 2019, space is limited to 100 participants! Sign-up Early.
Time: 11:00 a.m. – 12:00 p.m. EDT
Duration: 60 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
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The International Organization for Standardization (ISO) is a network of national standard bodies that develop voluntary standards, some which are applicable in the clinical research field. Some countries or organizations adopt ISO standards as requirements. ISO standards are reviewed every five years, and it takes approximately three years to develop a new standard.
One important standard in clinical research is ISO 14155.
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The Food and Drug Administration (FDA) has released a draft guidance, “Rare Diseases: Natural History Studies for Drug Development”. We discussed another draft guidance released in January, “Rare Diseases: Common Issues in Drug Development” in our blog. The new draft guidance describes how natural history studies may be best used for drug development for rare diseases.
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What does ‘I’ stand for?
You have probably heard of the Five Whys approach to getting to root cause. ‘Why’ is a good question to ask - but not until you've dug around for more information first. After all, you are soon to find additional questions, such as: When did the problem start? - and - Where exactly is the problem? The ‘I’ step in the DIGR-ACT® solution helps through ‘Is - Is Not’ questions. They can help lead you to define the issue better but may also point you in the direction of the root causes.
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We are excited to announce that eLearning courses are now available for purchase in our Clinical Pathways store, with more courses coming soon! All courses are available at a special introductory rate through April 30th.
One of our key eLearning courses is our Good Clinical Practice (GCP) training, updated with the latest from ICH E6 (R2) Addendum.
