FDA Drug Safety Communication: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age

  Safety AnnouncementAdditional Information for Patients and CaregiversAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [12-14-2010] The U.S. Food and Drug Administration (FDA) is warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. Benzonatate is a prescription drug approved for relief…

Cord Blood Banking – Information for Consumers

December 7, 2010 Expecting a baby can be a very exciting time for soon-to-be-parents. It can also be very confusing, with many decisions to make. One choice prospective parents often face is whether to donate, bank or discard their baby’s cord blood. Did you know that the Food and Drug Administration (FDA) regulates cord blood?…

Cord Blood Banking – Information for Consumers, December 7, 2010

Expecting a baby can be a very exciting time for soon-to-be-parents. It can also be very confusing, with many decisions to make. One choice prospective parents often face is whether to donate, bank or discard their baby’s cord blood. Did you know that the Food and Drug Administration (FDA) regulates cord blood? Here is some…

Remarks: MassMEDIC FDA Update Conference, December 1, 2010

Remarks Jeffrey Shuren, M.D., J.D., Director FDA’s Center for Devices and Radiological Health MassMEDIC FDA Update Conference Dec. 1, 2010 In August 2010, FDA’s Center for Devices and Radiological Health, or CDRH, released for public comment the preliminary reports from the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory…