Regulatory Affairs

FDA approves anti-clotting drug Savaysa

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration has approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

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FDA warns consumers about fraudulent Ebola treatment products

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.

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FDA issues guidance to support the responsible development of nanotechnology products

The U.S. Food and Drug AdministrationThree final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.

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FDA launches openFDA to provide easy access to valuable FDA public data

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration has launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.

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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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