EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications
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- Category: EMA
The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications.
FDA approves new drug to treat HIV infection
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- Category: FDA
The U.S. Food and Drug Administration has approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.
FDA alerts companies to stop illegal sale of treatments for diabetes
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- Category: FDA
The U.S. Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. The agency recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law.
FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies
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- Category: FDA
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.
FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers
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- Category: FDA
The U.S. Food and Drug Administration announced that the U.S. is now a "listed" countrydisclaimer icon with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.
FDA budget requests $4.7 billion
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- Category: FDA
The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.
FDA alerts health care providers of recall of anemia drug Omontys
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- Category: FDA
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.
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- FDA expands use of Xarelto to treat, reduce recurrence of blood clots
- FDA takes action against thousands of illegal Internet pharmacies
- FDA approves new treatment for advanced colorectal cancer