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FDA Alerts

FDA and industry reach agreement in principle on medical device user fees

February 1, 2012

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as [...]

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FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer

January 31, 2012

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment. This is a [...]

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FDA takes action against New York cheese manufacturer

January 31, 2012

The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria. This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The [...]

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FDA approves Kalydeco to treat rare form of cystic fibrosis

January 31, 2012

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene. This is a summary of a Press Release issued by the Food and [...]

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FDA approves new treatment for most common type of skin cancer

January 30, 2012

Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has [...]

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FDA approves Inlyta to treat patients with a type of advanced kidney cancer

January 27, 2012

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to [...]

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Department of Justice files Consent Decree of Permanent injunction against Ranbaxy

January 25, 2012

Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions [...]

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Maine company holds cold smoked salmon product after FDA order

January 24, 2012

A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below [...]

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FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri

January 20, 2012

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD). This is a summary of a Press Release issued by the [...]

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FDA approves Voraxaze to treat patients with toxic methotrexate levels

January 17, 2012

The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure. This is a [...]

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