CPSC and FDA Warn Against Using Infant Sleep Positioners Because of Suffocation Risk: Initial Communication

Date Issued: Sept. 29, 2010 Audience: Parents of infants younger than 1 year old Health Care Providers: Pediatricians, Nurse Midwives, Pediatric Nurse Practitioners, Neonatal Nurses, Obstetricians, Obstetric Nurses, Family Nurse Practitioners, Family Physicians, Home Health Care Nurses, Maternal and Child Care Nurses, Children’s Hospitals, Hospital Administrators, Lactation Consultants, Doulas, Childbirth Educators, Visiting Nurses, and Social [...]

Draft Guidance for Industry and FDA Staff

This guidance document is being distributed for comment purposes only. Document issued on: September 28, 2010 Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.  Submit written comments to the Division of Dockets Management (HFA-305), [...]

Information Regarding Insulin Storage and Switching Between Products in an Emergency

Back to Natural Disaster Response Insulin Storage and Potency Insulin from various manufacturers is often made available to patients in an emergency and may be different from a patient’s usual insulin. After a disaster, patients in the affected area may not have access to refrigeration.  According to the product labels from all three U.S. insulin [...]

Information Regarding Insulin Storage and Switching Between Products in an Emergency

Back to Natural Disaster Response Insulin Storage and Potency Insulin from various manufacturers is often made available to patients in an emergency and may be different from a patient’s usual insulin. After a disaster, patients in the affected area may not have access to refrigeration.  According to the product labels from all three U.S. insulin [...]

Guidance for Industry and FDA Staff – Impact

Document issued on: September 2, 2010 This document supersedes Impact-Resistant Lenses: Questions and Answers, September 1987. The draft of this document was issued on October 26, 2007. For questions regarding this document contact John Stigi at 301-796-5848 or john.stigi@fda.hhs.gov. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Division [...]

Medical Devices Technology Innovation Partnership (MD-TIP) Workshop, October 26, 2010

Department of Health and Human Services U.S. Food Drug Administration (FDA) and The Rector and Visitors of the University of Virginia (UVA ) present a co-sponsored Medical Devices Technology Innovation Partnership (MD-TIP) Workshop FDA White Oak Campus Building 31 Silver Spring, Maryland Tuesday October 26, 2010 Title: “Innovation, Technology Transfer and Scientific Interchange: Leveraging Academic [...]

AAMI and FDA Summit on Infusion Devices, Oct 5-6, 2010 (Registration Deadline September 24)

MARK YOUR CALENDAR!! The Association for the Advancement of Medical Instrumentation (AAMI) and the U.S. Food and Drug Administration (FDA) invite you to participate in a special summit focusing on critical issues surrounding infusion devices — October 5-6, 2010, at the FDA Headquarters in Silver Spring, MD. Infusion pumps are among the most crucial and [...]

Safe Drug Use After a Natural Disaster

Back to Natural Disaster Response The Center for Drug Evaluation and Research (CDER) at the FDA offers the following information on the use of drugs that have been potentially affected by fire, flooding or unsafe water and the use of temperature-sensitive drug products when refrigeration is temporarily unavailable. Drugs Exposed to Excessive Heat, such as [...]

FDA Drug Safety Communication: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction

  Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Data Summary Approved Gadolinium Based Contrast Agents   Safety Announcement [09-09-2010] The U.S. Food and Drug Administration (FDA) is requiring changes in the drug label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition [...]

FDA Drug Safety Communication: New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [09-15-2010] The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, [...]