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February 16, 2012
FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.
February 15, 2012
The EMA has published a guideline that addresses the influence of patients? genetic variability on drug pharmacokinetics.
February 09, 2012
After months of anticipation, the Food and Drug Administration issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.
February 02, 2012
More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.
The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The decree was filed on Jan. 25, 2012, and is subject to court approval.
January 05, 2012
The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.
January 02, 2012
The European Union market takes steps toward continuous processing and modular facilities.
December 01, 2011
EMA Hosts Subgroup Analysis Workshop.
November 10, 2011
EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification.
November 01, 2011
In an age dominated by the internet and uncertainty over the best packaging security methods to employ, counterfeit medicines have the ideal environment to thrive.