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Tag: clinical trials

How Decentralized Oracles And Smart Contracts Will Shape Web 3.0

Photo by Mourizal Zativa on Unsplash The DeFi market cap is approximately $64 billion, according to CoinMarketCap, a leading crypto data aggregator. The introduction of...

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DRAP Guidance on Clinical Trials Applications: Documents

The new article describes in detail the aspects related to the documents the authority expects the applicant to submit concerning the clinical trials.  ...

DRAP Guidance on Clinical Trials: Registries and Investigator’s Brochure

The new article describes specific aspects related to the registries containing information about clinical trials, and also to the Investigator’s Brochure – a particular...

DRAP Guidance on Clinical Trials Applications: CGP Compliance Audits and Reports

The new article describes in detail the regulatory matters related to audits or inspections for GCP compliance, as well as the reports and final...

DRAP Guidance on Clinical Trials: Import, Timelines, and Ethical Approval

The new article provides additional details regarding the regulatory requirements for the importation of investigational products, as well as other aspects.  Table of ContentsThe...

DRAP Guidance on Clinical Trials: Application in Detail

The new article describes in detail the procedure to be followed when applying for permission to conduct clinical trials in Pakistan.  Table of ContentsThe...

Cancer Drug with 100% Success Rate Achieved

Cancer could become a curable ailment in the future. In an early-stage clinical experiment, Memorial Sloan Kettering Cancer Center researchers obtained remarkable results: total cancer...
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DRAP Guidance on Clinical Trials Applications: Overview

The article provides an overview of Pakistan’s regulatory framework for clinical trials and applications to be submitted by interested parties.  Table of ContentsThe Drug...

HSA Guidance on Essential Principles: General Provisions and Clinical Trials

The new article addresses specific aspects regarding the Essential Principles medical devices should comply with to be allowed for marketing and use in Singapore....

FDA on Clinical Studies for Glycemic Control Devices: Specific Aspects

The new article highlights specific aspects related to the clinical studies and the way they should be undertaken to ensure the accuracy and reliability...

FDA Guidance on Clinical Studies for Glycemic Control Devices: Duration and Inclusion/Exclusion Criteria

The article addresses the aspects related to the study duration, and also the inclusion/exclusion criteria to be considered.  The document constitutes a draft guidance...

FDA Guidance on Clinical Studies for Glycemic Control Devices: Overview

The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control.  The document constitutes a draft guidance the...
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