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CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AuroBlog - Aurous Healthcare Clinical Trials blog

All the medical devices including in-vitro diagnostic medical devices have come under the regulation […]

In-Vitro 189
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Skipping Informed Consent for In Vitro Diagnostic (IVD) Trials: Understanding the Exceptions

Cloudbyz

Understanding the exceptions in Informed consent is an essential aspect of ethical clinical research because it concerns full awareness of risks and benefits related to research, as well as procedures. Per 21 CFR 50.23, “The waiver or alteration will not adversely affect the rights and welfare of the subjects.”

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Exploring the Future of Oncology with ADCs and TILs: Key Insights From ASCO  

Worldwide Clinical Trials

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

Antibody 162
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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

XTalks

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

Trials 97
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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? Information on social media and digital channels should be kept up to date and date stamped, with the date posted or last updated.

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Beginner’s Guide to IRB Review of IVD Research

Advarra

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., IVDs are used in almost all clinical research. IVDs are used in almost all clinical research. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants.

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The Challenges and Promise of CAR T-Cell Therapy in Oncology

XTalks

Vittoria Biotherapeutics is a clinical-stage cell therapy company that incorporates the latest advancements in cell therapy and gene editing with a unique approach that potentially overcomes some of the issues with this therapeutic modality. Such challenges highlight a significant unmet need and call for further advancements in the field.