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Republican House members introduce legislation to combat prescription drug abuse through partnerships between industry, retail and government. Read More
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
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
New data collection methods show more trials than previously thought need to meet their postmarketing requirements (PMR) and postmarketing commitments (PMC), a new FDA report says. Read More
After fielding nothing but complaints with its proposed generic drug safety labeling rule, the FDA is receiving rare support for the proposal from a coalition of patient groups that says it would give injured consumers a clear avenue for redress. Read More
BI subsidiary Ben Venue is recalling a lot of acetylcysteine 10 percent USP, after a single glass particle was seen in a single vial of the drug. Read More
The FDA is investigating whether it is requiring drugmakers to present too much risk information in direct-to-consumer (DTC) television ads, which could lead to a potentially drastic departure from current marketing regulation. Read More