Recently added articles from Adverse Event Reporting News:
Joint FDA-EMEA effort seen yielding extra safety data for drug approval.(Biomarkers/International)(European Medicines Agency )
Jun 17, 2008; ... FDA and the European Medicines Agency (EMEA) will allow drug companies to submit a single application to each agency with the results of seven new tests that evaluate kidney damage during animal studies of new drugs. Announcing the details June 12, FDA said the tests measure the ...
EU urges more collaboration after heparin scandal.(European Medicines Agency)(European Union)
Jun 17, 2008 ... Western drug agencies need to step up cooperation to head off a repeat of the recent scandal over tainted heparin and protect patients from counterfeits, the head of EMEA said June 6, according to Reuters. "Heparin is a classic example of how things can go wrong," Thomas ...
Epilepsy drugs draw industry defense.
Jun 17, 2008 ... Drug companies are scrambling to try to convince FDA not to add warnings for suicidal behavior risks to a large class of epilepsy drugs also used widely for a variety of other conditions, "The Wall Street Journal" reported June 4. On June 1, at a closed meeting of epilepsy ...
Bush formally asks Congress for $275 million to enhance drug safety; Spector critical of funds timing.(Drug safety)
Jun 17, 2008 ... After some reluctance, the Bush administration June 9 formally asked Congress for an increase of $275 million above its current budget request to enhance food and drug safety programs, according to Reuters. The White House initially requested an FDA budget of $2.4 billion for ...
FDA reviewing arthritis drugs for childhood cancer link.(Food and Drug Administration)
Jun 17, 2008 ... FDA issued an Early Communication about an ongoing safety review to investigate a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. The agency is investigating ...