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The number of drug safety reports filed with the European Medicines Agency (EMEA) increased dramatically last year with the implementation of mandatory electronic filing, according to the EMEA’s annual report.
An analyst is warning that the $9 million in punitive damages awarded to another plaintiff last week in the Vioxx trial in New Jersey sets a dangerous “negative precedent” for future litigation against drugmaker Merck.
The FDA issued an update of its public health alert on the abortion drug Mifeprex, saying the agency has been informed of six deaths in the U.S. following medical abortions with Mifeprex and misoprostol.
The House Oversight and Investigations Subcommittee will hold a hearing March 29 to address hospital-acquired infections. Lawmakers are concerned there is no consistent reporting standard for such infections.
FDA officials are calling for new warnings about the possible risks of psychosis or mania associated with drugs that treat attention deficit/hyperactivity disorder (ADHD).
A bipartisan coalition of lawmakers has introduced legislation requiring electronic tracking of prescription drugs to prevent a growing problem with counterfeit medications, but some critics say the bill does not go far enough in immediately addressing the problem.
While known more for its consumer products in other markets, Procter & Gamble (P&G) has some 3,600 employees in its pharmaceutical unit and the company recognizes that smart, proactive risk assessment makes sense on both a regulatory and an operational level, a P&G manager said.
The Agency for Healthcare Research and Quality’s (AHRQ) initiative to recommend preferred treatment options for a variety of health conditions could limit access to some medical therapies, especially if AHRQ’s efforts focus unduly on costs, say pharmaceutical and device manufacturers.
Proponents of radio frequency identification (RFID) tags received a boost earlier this month when Pfizer said it had begun to ship its first product – Viagra – with the tags embedded.
Many organizations mistakenly leave the decisionmaking for computer system and edata security up to the IT staff instead of higher level management, warns a new white paper from NetIQ.