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Pharmacovigilance is the practice of protecting public health by detecting, assessing, and managing potential adverse […]
Introduction: The drug development process for hit-to-lead molecules relies inevitably on the knowledge of adequate […]
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).
Modern technology solutions for Pharmacovigilance are required to solve the emerging needs in the area […]
The pharmaceutical market is highly regulated, and any misstep can lead to product recall that […]
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).
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.
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.