Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alert

07 Temmuz, 2022

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Patient Safety in the EU

07 Temmuz, 2022

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List of medicines under additional monitoring

07 Temmuz, 2022

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Naproxen CV Safety vs Ibuprofen Challenged in WHI Analysis

ALLAS, TX — Contrary to a lot of observational data and common belief even among clinicians, regular intake of naproxen entails more cardiovascular risk than ibuprofen, according to an analysis o

07 Temmuz, 2022

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FDA Launches Big Data 'openFDA' Initiative, Giving Public Easier Access to Safet

The US Food and Drug Administration (FDA) has launched a long-awaited technology initiative intended to free regulatory data that was once difficult to obtain and harder still to make sense of.

07 Temmuz, 2022

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EMA to Allow Biosimilar Applications to Reference Data from Products Approved Ou

The European Medicines Agency has updated its guidance for pharmaceutical companies on biosimilar medicines to reflect the European Commission's confirmation....

07 Temmuz, 2022

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Off-Label Use & Safety

There has been a lot of discussion regarding the off-label use of drugs.  This has been a focus of interest for FDA, EMA, MHRA and other health agencies around the world

07 Temmuz, 2022

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Severe Skin Reactions Investigated With Valsartan in Japan

Michael O\'Riordan KYOTO, Japan — The Japanese Health, Labor, and Welfare Ministry is currently investigating a potential a link between valsartan (Novartis) and skin eruptions that result in sores

07 Temmuz, 2022

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