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The EU’s new pharmacovigilance law could cost drugmakers fees totaling as much as $330,000 for each drug they make to cover postmarketing assessments. The EU proposed the fees, divided into two categories, Thursday as a way to pay for the reviews mandated under the 2010 law. Read More
The FDA plans to tell drugmakers by the end of November how they should exchange data with supply chain partners to satisfy new federal track-and-trace requirements. Read More
European regulators have turned down drugmakers’ requests to allow generic labeling of pandemic vaccines, which sponsors argue would help get their drugs to patients much sooner. Read More
Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Wednesday revealed that its Polish plant is at the center of a recall of an anesthetic product. Read More
When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
Purdue Pharma wants immediate-release opioids subjected to the restrictive labeling and postmarketing studies now required for extended release and long-acting (ER/LA) products such as the company’s flagship drug OxyContin. Read More
The FDA and European Medicines Agency (EMA) have launched a new information-sharing initiative they hope will coordinate and speed international responses to drug safety problems. Read More
The FDA is examining how drug manufacturers exchange transaction data with their business partners to see if data-gathering methods already in use could satisfy new federal track-and-trace requirements. Read More
Dynavax is withdrawing a European marketing authorization application for the Heplisav hepatitis B vaccine over concerns with adequate safety information. Read More