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Tag: fda
FDA rejects 2 HIV drugs from Gilead Sciences
2013-04-29 19:18:37| Biotech - Topix.net
Gilead Sciences Inc. said Monday that the Food and Drug Administration rejected two marketing applications for HIV treatments, citing quality control problems at the company's manufacturing facilities.
Recommended: FDA finds fraudulent Botox in the U.S.
2013-04-27 00:35:18| Biotech - Topix.net
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Passive Needle Guard features FDA 510(k) clearance.
2013-04-24 14:30:05| Industrial Newsroom - All News for Today
Designed to meet complex biotechnology drug requirements, BD UltraSafe PLUS™ offers needlestick safety in one-handed device that integrates ergonomic features which foster comfort and support for healthcare providers and patients. Plunger rod helps support injection of viscous drugs, while size of drug inspection window promotes drug visibility. This anti-needlestick safety device also has built-in finger flanges and plunger head that increase injection support and stability. This story is related to the following:Guards
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FDA Warns Against Misinterpretation of Antibiotic Resistance Data
2013-04-23 16:39:00| National Hog Farmer
Source: The Food and Drug Administration Recently, the Environmental Working Group issued a report of its interpretation of the 2011 Retail Meat Annual Report of the National Antimicrobial Resistance Monitoring System (NARMS). FDA officials said: “While FDA is always concerned when we see antimicrobial resistance, we believe the EWG report oversimplifies the NARMS data and provides misleading conclusions. We do not believe that EWG fully considered important factors that put these results in context, including: read more
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FDA Extends Food Safety Comment Period
2013-04-22 20:46:00| National Hog Farmer
By P. Scott Shearer, Bockorny Group, Washington, DC The Food & Drug Administration (FDA) announced it was extending the comment period for the Food Safety Modernization Act (FSMA) proposed rules for another 120 days. read more
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