Regulatory Affairs

FDA requires removal of certain restrictions on the diabetes drug Avandia

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. The actions are consistent with the recommendations of expert advisory committees.

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EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications

The European Medicines AgencyThe 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.

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FDA approves new drug to treat HIV infection

The U.S. Food and Drug AdministrationThe 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.

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FDA alerts companies to stop illegal sale of treatments for diabetes

The U.S. Food and Drug AdministrationThe 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.

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FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies

The U.S. Food and Drug AdministrationThe 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.

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FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers

The U.S. Food and Drug AdministrationThe 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.

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FDA budget requests $4.7 billion

The U.S. Food and Drug AdministrationThe 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.

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