FDA Requests $4.03 Billion to Promote and Protect Public Health
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- Category: FDA
The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the Presidentâs fiscal year 2011 budget - a 23 percent increase over the agencyâs current $3.28 billion budget.
FDA Commissioner Addresses Nation's Healthcare Professionals on H1N1 Vaccine
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- Category: FDA
Dr. Margaret Hamburg, Commissioner of Food and Drugs, sent a letter to America's healthcare professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on the safety of the 2009 H1N1 vaccines.
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
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- Category: FDA
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.
European Medicines Agency implements internal reorganisation
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- Category: EMA
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.
FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR
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- Category: FDA
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.
The bacterial challenge - time to react
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- Category: EMA
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).
FDA: Cancer Warnings Required for TNF Blockers
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- Category: FDA
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.
More Pharma News ...
- European Medicines Agency review of pandemic vaccines underway
- FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene
- European public health agencies evaluate antibiotic resistance of Staphylococcus aureus
- European Medicines Agency recommendations on extension of shelf life for Tamiflu
- EMEA-coordinated PROTECT project has been accepted for funding
- EMEA, EC and Health Canada agree implementation plan for confidentiality arrangement
- EMEA recommends suspension of the marketing authorisation of Raptiva (efalizumab)