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19 MINS AGO - Yahoo! News

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U.S. FDA panel reviews Baxter immune therapy's long-term safety

By Toni Clarke Washington (Reuters) - Advisors to the U.S. Food and Drug Administration will meet on Thursday to discuss the relative risks and benefits of Baxter International Inc's experimental treatment for certain hereditary disorders of the immune system. The FDA on Wednesday posted its preliminary assessment of the data on its website. The FDA is not obligated to follow ...

Tags: U.S. FDA panel reviews Baxter immune therapy's long-term safety,  Food And Drug Administration Latest News

15 HOURS AGO - Yahoo! News

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FDA Oks expanded use of Regeneron's eye drug

(Reuters) - Regeneron Pharmaceuticals Inc said the U.S. Food and Drug Administration has approved the expanded use of its eye drug Eylea for the treatment of diabetic macular edema. Eylea is already approved in the United States to treat wet age-related macular edema — the leading cause of blindness in the elderly, and for treatment of macular edema following central ...

Tags: FDA Oks expanded use of Regeneron's eye drug,  Food And Drug Administration Latest News

JUL 29, 2014 - Yahoo! News

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Impax Parkinson's drug future shaky as FDA flags factory issues

(Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration raised concerns about the company's factory in Taiwan, casting in doubt the future of its Parkinson's drug, rytary. Shares of Impax, which makes generics and specialty drugs to treat central nervous system disorders, fell as much as 17 percent on Tuesday, after the regulator listed 10 violations at ...

Tags: Impax Parkinson's drug future shaky as FDA flags factory issues,  Food And Drug Administration Latest News

JUL 29, 2014 - Fox News

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House passes bill to speed FDA's sunscreen approvals

The House passed legislation Monday to require the Food and Drug Administration to speed approval of new types of sunscreen in the wake of a regulatory backlog that has stalled their introduction

Tags: House passes bill to speed FDA's sunscreen approvals,  Food And Drug Administration Latest News

JUL 29, 2014 - Yahoo! News

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FDA raises concerns about Impax's Taiwanese plant

(Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration issued "certain observations" after an inspection of the company's manufacturing plant in Taiwan. The regulator issued a ten observations in a Form 483, which is usually issued when inspectors find conditions that may violate U.S. rules. "The FDA did not provide any status or classification to these observations," ...

Tags: FDA raises concerns about Impax's Taiwanese plant,  Food And Drug Administration Latest News