The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH).
Category Archives: Drug Safety Information Podcasts
FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards
FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards
FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer
The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.
FDA approves Firazyr to treat acute attacks of hereditary angioedema
The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.
FDA working with Mexico to protect safety of imported papayas
The U.S. Food and Drug Administration (FDA) and its counterpart agencies in the Mexican government, the National Service for Agroalimentary Public Health, Safety and Quality (SENASICA) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), are expanding their collaboration to reduce the risk of contamination of food that moves across the U.S.-Mexican border.
FDA requests seizure of adulterated seafood at California company
At the request of the U.S. Food and Drug Administration, U.S. Marshals, yesterday, seized seafood products manufactured by the Meiko Food Co., South El Monte, Calif., because the products are adulterated.
FDA hurricane preparedness checklist
The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after this week’s expected hurricane-related rain, possible flooding and power outages.
FDA approves Botox to treat specific form of urinary incontinence
The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.
FDA approves Adcetris to treat two types of lymphoma
The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).
FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer
The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.