Tag: Drug Safety

EMA’s PRAC Starts Review of Leuprorelin Medicines

EMA’s safety committee (PRAC) has started a review of leuprorelin medicines after reports indicated that handling errors during preparation and administration can cause some patients to receive insuff...

EMA to Launch Safety Review of Alemtuzumab

The European Medicines Agency (EMA) has launched a safety review of alemtuzumab following reports of two deaths and several other cases of people experiencing life-threatening reactions shortly after ...

EMA Launches Social Media Campaign on Medicines Regulation in EU

EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines available in Europe safe and effective. As of today, EMA will start sharing a series of ...

Improved EudraVigilance Receives More Reports

The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse reactions to medicines that are authorised or being studied in clinical trials in t...

Pilot Project for Drug Supply Chain Security Act of FDA

fda office
A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products FDA regulates, including drugs available to consumers, are safe and of high quality. ...

New Safety Features for EU Medicine

As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) a...

WCG Partners with Prudentia for Enhancing Compliance

Aims to deliver a comprehensive solution aimed at enhancing the quality, safety and regulatory compliance of adverse event monitoring in drug development. The WIRB-Copernicus Group's (WCG) Clinical...