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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.
Co-authored by our own Sandra SAM Sather, MS, BSN, RN, CCRC, CCRA and Julie Blasingim, MBA, CIP, “An IRB Perspective on Improving Informed Consent” was published in the April 2018 issue of the Association of Clinical Research Professionals’ (ACRP’s) peer-reviewed journal, Clinical Researcher.
What is the GDPR?
The European Union’s (EU) General Data Protection Regulation (GDPR) goes into effect on May 25, 2018. The purpose of the GDPR is to protect the privacy and security of personal data and to strengthen the accountability to those using personal data.
Background
Women were underrepresented at under 20% of subjects in clinical trials in the 1990s.
The Food and Drug Administration (FDA)’s Office of Women’s Health (OWH) was formed in 1994 with a mission to ensure adequate involvement of women in clinical trials and to identify specific requirements and challenges for women’s health.
Clinical Trials Day recognizes clinical trials professionals’ contributions to the advancement of medicine and public health. It is celebrated yearly on May 20th globally in remembrance of what is believed to be the first randomized clinical trial. During a time when scurvy killed many at sea, James Lind, the surgeon aboard the HMS Salisbury of Britain’s Royal Navy, devised a “study” involving 12 men given one of six different treatments in May 1747. Those who were given citrus showed improvement. This is regarded as the beginning of clinical trial design.
There are concerns over how the United Kingdom’s (UK) departure from the European Union (EU), also known as Brexit, will affect clinical research stakeholders in the UK and the EU. Brexit will begin March 29, 2019. Since the European Medicines Agency (EMA) is a EU Agency, would that mean that the UK would no longer be a part of the Agency or follow the regulations set by it? What effects would the change have on harmonization of clinical trials through Europe and globally?
How does Brexit affect the EMA headquarters, and will it remain independent?
