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Clinical Research

FDA Updates Guidance to Address the Spread of Misinformation

FDA Updates Guidance to Address the Spread of Misinformation

10/10/2024

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The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily address misinformation about their medical products.

New Draft Guidance on Predetermined Change Control Plans for Medical Devices

New Draft Guidance on Predetermined Change Control Plans for Medical Devices

09/18/2024

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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.

FDA Announces Upcoming Webinar to Discuss the New Guidance for Industry: ICH M12 Drug-Drug Interaction Studies

FDA Announces Upcoming Webinar to Discuss the New Guidance for Industry: ICH M12 Drug-Drug Interaction Studies

09/10/2024

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In August 2024, the US Food and Drug Administration (FDA) released a final guidance for industry on drug-drug interactions (DDI) with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) titled: M12 Drug Interaction Studies. The guidance is intended to set the global standard and framework for conducting and reporting DDI studies in order to improve the efficacy of drugs as well as the safety and predictability of potential interactions between different drugs.

Navigating the FDA's Remote Regulatory Assessments (RRAs): A New Era in Oversight

Navigating the FDA's Remote Regulatory Assessments (RRAs): A New Era in Oversight

08/26/2024

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In an increasingly digital world, the U.S. Food and Drug Administration (FDA) is adapting its oversight mechanisms to include more technologically advanced approaches. One such adaptation is the use of Remote Regulatory Assessments (RRAs), a practice that has gained momentum, especially during the COVID-19 pandemic. In January 2024, the FDA released a revised draft guidance titled Conducting Remote Regulatory Assessments–Question and Answers, outlining the role and purpose of RRAs and how they compare to traditional in-person inspections.

FDA Issues Institutional Review Board (IRB) Warning Letter from RRA

FDA Issues Institutional Review Board (IRB) Warning Letter from RRA

08/08/2024

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On June 21, 2024, The U.S. Food and Drug Administration (FDA) sent a warning letter to Massachusetts Institute of Technology (MIT) outlining several violations observed during a remote regulatory assessment (RRA) of MIT’s Institutional Review Board (IRB). The remote regulatory assessment  was conducted as part of the FDA Bioresearch Monitoring Program (BIMO), which includes RRAs and inspections.