Regulatory Affairs Syndicator

Business briefsThe Herald, WA - 6 hours ago… has submitted its response to the Food and Drug Administration's Office of Generic Drugs regarding the agency's concerns about the Bothell company's … Fresh spinach returns to loca…

Energy drinks and food bars: Power or hype?Bradenton Herald,  United States - 4 hours ago… effect). Some contain herbal supplements that are not regulated by the Food and Drug Administration (FDA), such as ginseng. These …

Indianapolis Star - … drastic action, including selling its experimental drug, taking on a development partner to help pay for further testing, or swallowing hard and footing the bill itself for the additional patient tests demanded by the Food and Drug Administration.

XanGo and the FDASalt Lake Tribune, United States - 59 minutes ago… According to the Food and Drug Administration, that's exactly what XanGo is doing in promotional brochures, violating US law in the process. … FDA Slaps Juice Maker …

New Mexico Business Weekly - The latest wrinkle drug from Allergan Inc. is set to be available to some doctors and patients as early as next week. Juvederm, which was approved by the Food and Drug Administration in June, will initially offer the injectable drug through select …

The Food and Drug Administration warned consumers Friday night not to drink Bolthouse Farms Carrot Juice in certain packaging after linking a fourth case of botulism to the product.
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FDA is announcing today that all spinach implicated in the current outbreak has traced back to Natural Selection Foods LLC of San Juan Bautista, California.

US OKs new uses for Genentech, Biogen lymphoma drugReuters.uk, UK - 1 hour ago… This latest approval follows US Food and Drug Administration clearance of Rituxan in February for treatment of diffuse large B-cell lymphoma, a fast-growing ……

Earthtimes.orgFresh Spinach Cleared for Consumption AgainFood Consumer, IL - 4 hours ago… types of heart surgeries appears to increase users' risks of kidney failure, heart failure and stroke, the US Food and Drug Administration announc…

By Maggie Fox, Health and Science CorrespondentWASHINGTON - Fresh spinach is safe to eat in the United States because all E. coli-tainted spinach has been recalled, the U.S. Food and Drug Administration said on …
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By Lisa RichwineWASHINGTON - German drug maker Bayer AG “mistakenly” failed to inform U.S. regulators about a study on the risks of heart-surgery drug Trasylol before an advisory panel met and ruled the side …
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The U.S. Food and Drug Administration lifted its two-week-old consumer warning on most fresh spinach Friday, revising the alert to say it now covers only specific brands packaged on certain dates.
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ABC News - More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal,” the Food and Drug Administration said in an alert posted on its Web site at http://www.fda.gov/cder …

Conditional Nod for JNJ DrugTheStreet.com - 7 hours ago… Johnson& Johnson (JNJ - commentary - Cramer's Take) late Friday said that it has received an "approvable letter" from the Food and Drug Administration for its … J&…

Health care company Johnson & Johnson said late Friday it received an “approvable letter” from the Food and Drug Administration for its paliperidone extended-release tablets, requesting additional information on the schizophrenia treatment.