The latest datafoundry articles related to healthcare challenges, real world data and more...
Nov 18th, 2021

AI for Drug Safety Case Processing

The Drug Safety and Clinical Data Quality Act is a U.S. law that is meant to provide the FDA with more authority to regulate and enforce drug safety for consumers, as well as monitor clinical trials. The Act was enacted in 2012 and is currently enforced under the FDA’s Center for Drug Evaluation and Research (CDER).

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Nov 18th, 2021

AI-assisted Literature Monitoring and Review

It is estimated that top pharma companies and research institutions commission around 20 literature review projects each on an average per year. Regulatory agencies expecting a Literature Review section in key regulatory documents such as Safety Aggregate Reports, Clinical Evaluation Reports (CERs) for devices etc. Literature survey findings are used to strengthen the regulatory submissions for drugs, biologics and medical device authorizations. US FDA guidance requires literature surveys as sources of information on safety, efficacy and ‘other known uses’ information.

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Nov 18th, 2021

The Right Way to Approach the Challenges of Global Drug Safety and Pharmacovigilance

Drug safety is a major concern for healthcare professionals, patients, and the general public. Misuse of prescription drugs is responsible for an estimated 3 million emergency department visits each year in the United States.

The World Health Organization recently released data showing that worldwide drug-related deaths are estimated to reach 1.5 million in 2015, accounting for 2% of all deaths worldwide.

This is equivalent to four deaths per minute or approximately 117 every hour.

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Nov 18th, 2021

Importance and problems of Literature Monitoring and Review in Pharmacovigilance

The term ‘literature monitoring’ refers to the process by which adverse events or new drug efficacy data are detected in published sources. Literature review can be defined as a systematic examination of different studies about a given subject to come up with an overview of the entire topic. Literature monitoring is important to ensure that the medical professionals are aware of the latest research findings. Pharmacovigilance specialists monitor medical literature for adverse events, side effects, and new drug effectiveness.

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Oct 18th, 2021

AI in Drug Label Management

Label Management Label Management is a process which helps in complying with regulatory requirements and […]

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