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April 18, 2024: New Living Textbook Chapter Articulates How Investigators Navigated Unexpected Challenges During Pragmatic Clinical Trials

Rethinking Clinical Trials

Section 2 : Study teams responded to staff turnover, leadership changes, and health system acquisitions and mergers. Section 3 : Rapid technology change created unexpected consequences, such as EHR updates causing system changes that affected intervention delivery, and sites switching EHRs systems creating complexities during the trial.

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Laurus Labs and IIT Kanpur partner for new gene therapy products

Pharmaceutical Technology

Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmacovigilance in Clinical Trials: Safeguarding Participant Safety and Ensuring Data Integrity

Cloudbyz

This section outlines the importance of pharmacovigilance in identifying and minimizing risks, ensuring participant safety, and maintaining the integrity of clinical trial data. This section explains the process of adverse event collection, classification, and reporting.

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog

A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”

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FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020

JAMA Internal Medicine

This cross-sectional study evaluates regulatory decisions and health technology assessments in Australia, Canada, and the UK regarding new drugs approved by the US Food and Drug Administration in 2017 through 2020, as well as estimates the US cost per patient per year for drugs receiving negative recommendations.

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STAT+: Ahead of genome summit in London, questions linger about CRISPR baby scandal

STAT News

That technology, which enables scientists to easily excise, alter, or replace specific sections of DNA, was awarded the 2020 Nobel Prize for Chemistry. Next week, hundreds of scientists from around the world will convene in London for an international summit on genome editing.

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SLAS2024 update: The technology behind nanoparticle-based vaccines

Drug Discovery World

This year the programme will feature a track curated by DDW taking place in the Ignite Theater ‘ Innovation & technology: from lab to patient ’. Technology plays multiple roles in all stages of vaccine development,” Kanekiyo said. “It Will you be attending SLAS2024 in Boston?