Posts tagged with the keyword: ‘fda’

FDA Fines American Red Cross $16 Million for Prior Failures to Meet Blood Safety Laws

FDA Fines American Red Cross $16 Million for Prior Failures to Meet Blood Safety Laws

The FDA announced today that the American Red Cross has been fined $16 million for prior failures to comply with Federal laws and regulations related to the collection and manufacture of blood products. Despite the compliance failures, FDA found no evidence that the Red Cross violations endangered any patients and the blood supply is believed [...]

FDA says Healthcare Providers Can Resume Use of Rotarix

FDA says Healthcare Providers Can Resume Use of Rotarix

PHILADELPHIA, May 14 — GlaxoSmithKline (NYSE: GSK) announced that the Food and Drug Administration (FDA) has determined that U.S. healthcare practitioners can resume the use of Rotarix® (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the FDA’s recommendation from March 22, 2010 and reflects the agency’s assessment that the presence of porcine circovirus type [...]