FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
The U.S. Food and Drug Administration warns consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.
Read more ...
European Medicines Agency implements internal reorganisation
The European Medicines Agency has begun implementing a series of changes to its internal organisation aimed at improving the functioning of the Agency and the way in which it delivers its core tasks. The changes will be introduced gradually from September to December 2009.
Read more ...
FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR
The U.S. Department of Health and Human Services (HHS) marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.
Read more ...
The bacterial challenge - time to react
There is a need for more development of antibiotics that are effective against multidrug-resistant bacteria. That is the conclusion of a new report prepared jointly by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA) with contributions from the international network Action on Antibiotic Resistance (ReAct).
Read more ...
FDA: Cancer Warnings Required for TNF Blockers
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.
Read more ...
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.
Read more ...
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.
Read more ...