Jul27
To: HEALTH, MEDICAL, AND NATIONAL EDITORSContact: Elaine Gansz Bobo of the U.S. Food and Drug Administration, +1-301-796-7567, elaine.bobo@fda.hhs.gov, Consumer Inquiries: 888-INFO-FDASILVER SPRING, Md., July 28 /PRNewswire-USNewswire/ The U.S. Foodand Drug Administration today approved Cuvposa (glycopyrrolate) OralSolution to treat chronic severe drooling caused by neurologicdisorders in children ages 3 years to 16 years.(Logo: is [...]
Jul12
Company must provide transition guide for facilities using Colleague infusion pumpsSILVER SPRING, Md., July 13 /PRNewswire-USNewswire/ The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement [...]
Jul5
Device designed to help those with end-stage, age-related macular degenerationSILVER SPRING, Md., July 6 /PRNewswire-USNewswire/ The U.S. Food and Drug Administration today announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage, age-related macular degeneration (AMD).(Logo: (Logo: Surgically implanted in one eye, the IMT is a small [...]
Jul5
FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD PatientsDevice designed to help those with end-stage, age-related macular degenerationSILVER SPRING, Md., July 6 The U.S. Food and Drug Administration today announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage, age-related macular degeneration (AMD).Surgically implanted [...]
Jun20
To: HEALTH, MEDICAL, AND NATIONAL EDITORSContact: Dick Thompson of U.S. Food and Drug Administration, +1-301-796-7566, dick.thompson@fda.hhs.govParticipants will explore how federal agencies can encourage medicaldevice developmentSILVER SPRING, Md., June 21 /PRNewswire-USNewswire/ Each day,medical devices from renal dialysis machines to implantabledefibrillators help prevent, diagnose, treat, and monitor serious andlife-threatening diseases. After taking years to develop, [...]
Jun20
Participants will explore how federal agencies can encourage medical device developmentSILVER SPRING, Md., June 21 /PRNewswire-USNewswire/ Each day, medical devices from renal dialysis machines to implantable defibrillators help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. [...]
Jun20
Participants will explore how federal agencies can encourage medical device developmentSILVER SPRING, Md., June 21 /PRNewswire-USNewswire/ Each day, medical devices from renal dialysis machines to implantable defibrillators help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. [...]
Jun14
To: FAMILY, HEALTH, AND NATIONAL EDITORSContact: Siobhan DeLancey of FDA, +1-301-796-4668, siobhan.delancey@fda.hhs.govSILVER SPRING, Md., June 15 /PRNewswire-USNewswire/ The Food andDrug Administration today alerted parents and caregivers that someliquid Vitamin D supplement products are sold with droppers that couldallow excessive dosing of Vitamin D to infants. (Logo: FDA also advised manufacturers of liquid Vitamin [...]
Jun6
To: FOOD, HEALTH, AND NATIONAL EDITORSContact: Rita Chappelle of FDA, +1-301-796-4672 or +1-240-753-8603, rita.chappelle@fda.hhs.govProducts made under conditions that violated federal lawSILVER SPRING, Md., June 7 /PRNewswire-USNewswire/ Lifesoy Inc., aSan Diego-based manufacturer of ready-to-eat soy products cited by theU.S. Food and Drug Administration for preparing, packing, and holdingarticles of food under insanitary conditions, has [...]
Jun6
Products made under conditions that violated federal lawSILVER SPRING, Md., June 7 /PRNewswire-USNewswire/ Lifesoy Inc., a San Diego-based manufacturer of ready-to-eat soy products cited by the U.S. Food and Drug Administration for preparing, packing, and holding articles of food under insanitary conditions, has entered into a consent decree of permanent injunction in the U.S. [...]
