The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn's disease, and other inflammatory diseases.
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European Medicines Agency review of pandemic vaccines underway
The European Medicines Agency has started to receive data on H1N1 pandemic vaccines and the review began in July, with the commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available.
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FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene
The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.
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European public health agencies evaluate antibiotic resistance of Staphylococcus aureus
The European Food Safety Authority (EFSA), the European Centre for Disease Control and Prevention (ECDC) and the European Medicines Agency (EMEA) have published today a joint Scientific Report on meticillin resistant Staphylococcus aureus (MRSA) in livestock, pets and foods.
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European Medicines Agency recommendations on extension of shelf life for Tamiflu
The European Medicines Agency has recommended that the shelf life of Tamiflu capsules should be extended from five to seven years. Once formally approved by the European Commission, this will apply to all newly manufactured Tamiflu capsules.
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EMEA-coordinated PROTECT project has been accepted for funding
The PROTECT project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking (IMI JU). PROTECT is a collaborative European project aiming to develop innovative methods in pharmacoepidemiology and pharmacovigilance.
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EMEA, EC and Health Canada agree implementation plan for confidentiality arrangement
The European Medicines Agency, the European Commission and Health Canada, the Canadian regulatory authority for medicines, have agreed on an implementation plan for their confidentiality arrangement. The implementation plan details the process for both regular and ad-hoc exchanges of information, and describes the process for monitoring the progress of the implementation plan.
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The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn's disease, and other inflammatory diseases. 
The European Medicines Agency has started to receive data on H1N1 pandemic vaccines and the review began in July, with the commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available.