Archive for March, 2008
Industry lobbyists and White House try to keep food safety agents … - Seattle Post Intelligencer
Closed Published by Google Inc. March 28th, 2008 in Google FDA News, Regulatory AffairsIndustry lobbyists and White House try to keep food safety agents …Seattle Post Intelligencer - 21 hours agoFor the most part, all a consumer can get from the USDA or the Food and Drug Administration is that a recall is under way of product A, B…
FDA Seeks Civil Penalties from Calif. Device Maker
Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 28th, 2008 in Regulatory AffairsThe U.S. Food and Drug Administration (FDA) today announced it is seeking a 2.2 million dollar penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.
Chiquita Brands International, Inc. Recalls Whole Cantaloupes Grown by Agropecuaria Montelibano, Honduras, Due to Possible Health Risk (March 27)
Closed Published by Food and Drug Administration--Recalls March 28th, 2008Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk (March 27)
Closed Published by Food and Drug Administration--Recalls March 28th, 2008Lannett Company Receives FDA Approval for Bethanechol Chloride … - FOXBusiness
Closed Published by Google Inc. March 28th, 2008 in Google FDA News, Regulatory AffairsLannett Company Receives FDA Approval for Bethanechol Chloride …FOXBusiness - 3 hours ago… a manufacturer of generic pharmaceuticals, today announced that it has received approval from the US Food and Drug Administration (FDA) of its …Lannet…
Honduras: Cantaloupe Ban Criticized - New York Times
Closed Published by Google Inc. March 28th, 2008 in Google FDA News, Regulatory AffairsCNN InternationalHonduras: Cantaloupe Ban CriticizedNew York Times, United States - 2 hours agoBy MARC LACEY Officials are denouncing a Food and Drug Administration decision asking American grocers to stop selling cantaloupe imported from a H…
Consumer Information on: Dako FISH pharmDx™ Kit - P050045
Closed Published by CDRH Consumer News March 27th, 2008 in Regulatory AffairsTopics: Breast Cancer, Diagnostic Tests
Consumer Information on: FreeStyle Navigator® Continuous Glucose Monitoring System - P050020
Closed Published by CDRH Consumer News March 27th, 2008 in Regulatory AffairsThe FreeStyle Navigator Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and…
Balance of justice - San Francisco Chronicle
Closed Published by Google Inc. March 27th, 2008 in Google FDA News, Regulatory AffairsBalance of justiceSan Francisco Chronicle, USA - 2 hours agoPrescription drugs (2006): The Food and Drug Administration pre-empts state tort law in coming out with new rules that require drug manufacturers to warn …
FDA Warns Consumers about Total Body Formula and Total Body Mega Formula
Closed Published by Food and Drug Administration Press Releases March 27th, 2008 in Regulatory AffairsThe liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
FDA Looking At Diabetic Foot Drug and HIV Drugs - CNNMoney.com
Closed Published by Google Inc. March 27th, 2008 in Google FDA News, Regulatory AffairsThe Money TimesFDA Looking At Diabetic Foot Drug and HIV DrugsCNNMoney.com - 8 hours agoWASHINGTON -(Dow Jones)- The Food and Drug Administration said Thursday it's conducting a safety review of Regranex, a Johnson & Johnson (JNJ) gel appr…
FDA Looking At Diabetic Foot Drug and HIV Drugs - CNNMoney.com
Closed Published by Google Inc. March 27th, 2008 in Google FDA News, Regulatory AffairsDog Flu Diet and DiseasesFDA Looking At Diabetic Foot Drug and HIV DrugsCNNMoney.com - 12 hours agoWASHINGTON -(Dow Jones)- The Food and Drug Administration said Thursday it's conducting a safety review of Regranex, a Johnson & Johnson (JN…
Regranex Use May Increase Risk of Cancer - InjuryBoard.com
Closed Published by Google Inc. March 27th, 2008 in Google FDA News, Regulatory AffairsDog Flu Diet and DiseasesFDA Looking At Diabetic Foot Drug and HIV DrugsCNNMoney.com - Mar 27, 2008WASHINGTON -(Dow Jones)- The Food and Drug Administration said Thursday it's conducting a safety review of Regranex, a Johnson & Johnson (JN…
FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics
Closed Published by Food and Drug Administration Press Releases March 27th, 2008 in Regulatory AffairsThe U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.
Rates of Rare Mutations Soar Three to Four Times Higher in Schizophrenia
Closed Published by National Institutes of Health (NIH) News Releases March 27th, 2008 in NIHPeople with schizophrenia
have higher rates of rare genetic deletions and duplications that
likely disrupt the developing brain, according to studies funded
in part by the National Institutes of Health.
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