ARC Warning Letter and 483
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM287834.pdf Mr. J. Chris Hrouda Executive Vice President Biomedical Services American National Red Cross 2025 E Street, N. W. Washington, D.C. 20006 RE: United States v. American National Red Cross, Civil Action No. 93-0949 (JGP) Dear Mr. Hrouda: From April through October 2010, United States Food and Drug Administration (FDA) investigators inspected sixteen American National […]
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FDA fines Red Cross nearly $9.6 million for blood safety lapses
Federal health officials have fined the American Red Cross nearly $9.6 million for sloppy and unsafe blood management practices, the second multi-million-dollar penalty levied against the agency in the last two years. The new Food and Drug Administration fine follows inspections at 16 Red Cross blood centers between April and October 2010 that revealed ongoing […]
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Novartis rep: There’s no deal with Paula Deen
Novartis has no connection with chef Paula Deen and no plans to use her as its spokesperson, a spokesperson for the drug maker said Friday. Earlier Friday, a report out of The Daily surfaced, citing a source who said Deen had inked a deal to become a spokesperson for a Novartis drug used to treat […]
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Daiichi Sankyo officials to monitor new Ranbaxy unit
Daiichi Sankyo, the Japanese owner of Ranbaxy Laboratories, has deputed two executives to monitor the Indian drug maker’s new plant that will be the main source for supplying medicines for the US market. A person aware of the development said these two executives, who are at the general manager and director level, would be based […]
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Roche Refuses To Disclose Tamiflu Data: Scientists
An influential review that is due out tomorrow will not contain up-to-date efficacy information about Tamiflu, the widely used influenza drug sold by Roche, because researchers at the Cochrane Collaboration say they were stymied by the drugmaker in their efforts to fully assess the medication, according to reports. Iain Chalmers, one of the founders of […]
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J&J Marketed Risperdal for Kids After FDA Warnings, Jurors Told
The antipsychotic drug Risperdal was marketed for children and adolescents by Johnson & Johnson’s Janssen unit after warnings by the U.S. Food and Drug Administration not to do so, a witness told jurors. Janssen’s marketing to children began after the drug’s introduction in 1994 and continued until the FDA’s first approval for pediatric uses in […]
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American Red Cross Cited by FDA for Blood-Safety Rule Violations
The American Red Cross, the biggest U.S. supplier of donated blood, failed to correct violations of blood-safety rules, raising the risk that ill-suited blood will be used in transfusions, U.S. regulators said. The U.S. Food and Drug Administration fined the Red Cross $9.59 million, according to a letter from the agency to the Red Cross […]
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FDA Warns of Counterfeit Cancer Drugs
Shortages of some injectable cancer drugs have created an opening for dangerous unapproved versions of Roche Holding AG’s Herceptin and Amgen’s Neupogen to be sold to clinics and other healthcare providers, U.S. health officials said. The Food and Drug Administration issued a notice Friday warning providers to avoid direct solicitations from unproven sources and only […]
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FDA would collect millions in fees to speed review of traditional and biotech generic drugs
The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs, under an agreement with industry released by the agency on Friday. The user fee proposal is one of three such agreements that the agency is submitting to Congress […]
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FDA warns about PML risk with Seattle Genetics’ Adcetris
Seattle Genetics has suffered a setback on the news that US regulators have called for a boxed warning on the lymphoma drug Adcetris amid concerns of a link to a rare but potentially fatal brain infection. The US Food and Drug Administration said the warning needs to be added to the label after two additional […]
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