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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.
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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).
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The ICH Q9(R1) international guideline on Quality Risk Management reached step 4 on January 18, 2023. Step 4 is when the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulatory Members of the ICH Assembly have adopted the guideline as a harmonized guideline.
The United Kingdom (UK) notified the European Union (EU) of its intent to withdraw effective March 30, 2019, a process commonly known as Brexit. At that point, it will become a “third country” and will not follow the EU regulations for pharmaceuticals. Negotiations are underway for a withdrawal agreement. The European Medicines Agency (EMA) and the European Commission have released guidance related to pharmaceutical companies’ distribution of drugs due to the uncertainty of authorization of a withdrawal agreement.