Innovations + Investments in Healthcare Summit 2015

Regulatory Affairs

FDA approves first treatment for sexual desire disorder

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi's approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

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FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices sold online

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 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers.

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The U.S. Food and Drug AdministrationThree final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.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