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EMA on the use of Real-World Data/Evidence in ...

04/30/2025

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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.

EMA on the use of Real-World Data/Evidence in Non-Interventional Studies
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FDA Warning Letter to Sponsor – Records, ...

04/22/2025

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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails
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OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).

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WMA Adopts 2024 Revision of the Declaration of ...

03/24/2025

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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.

WMA Adopts 2024 Revision of the Declaration of Helsinki
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IRB Warning Letter from BIMO Inspection

03/10/2025

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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.

IRB Warning Letter from BIMO Inspection

OCR Guidance on Audio Only Telehealth

06/21/2022

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U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released “Guidance on How the HIPAA Rules Permit Covered Health Care Providers and Health Plans to Use Remote Communication Technologies for Audio-Only Telehealth” in June 2022, called “guidance on HIPAA and audio only telehealth” for clarity and brevity in this blog. This guidance clarifies how covered entities can provide audio only telehealth while complying with HIPAA Rules to protect the privacy and security of the participants or patients’ protected health information (PHI).

EMA Complex Clinical Trials Guidance Released

06/14/2022

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The European Medicines Agency (EMA) released a Complex Clinical Trials Questions and Answers guidance document in May 2022. Complex clinical trials (CCT) are defined as “being non-conventional in the sense that they have elements, features, methods or combination thereof, including novel approaches, that confer complexity of their designs, conduct, analyses or reporting.”

Bioavailability Studies for NDA or IND Guidance

06/07/2022

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The US Food and Drug Administration (FDA) released a guidance “Bioavailability Studies Submitted in NDAs or INDs – General Considerations” in April 2022. Bioavailability (BA) is defined as “the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.”