Group items tagged

The Medical Product Safety Network (MedSun) improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety. This website also provides public access to de-identified reports 2 sent into the MedSun program, in addition to important safety information to MedSun participants and to the national clinical community about reported problems.

National Program for Playground Safety - NPPS is the leader in research, training, and development of S.A.F.E. play areas! NPPS' mission is to help the public create safe and developmentally appropriate play environments for children. A premier non-profit organization in the United States delivering training and services about outdoor play and safety. NPPS serves as child-advocates on issues pertaining to playground safety before government and regulatory agencies. NPPS helps the public create, renovate, and maintain safe and developmentally appropriate play environments for children by providing professional, well-researched, highly informative, practical and user-friendly services, and programs to fulfill this mission. NPPS serves as a national resource for the latest educational and research information about playground safety.

MedWatch - FDA Safety Information and Adverse Event Report Program - MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.

Agency responsible for regulating the manufacture of disability modified vehicles.Child Passenger Safety: seat ratings, inspection stations, Recalls, defects, Latest studies and reports, fuel economy standards, highway safety programs and grants

Duke University and Multicenter, Open-label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Lacosamine (LCM) Oral Solution (syrup) as Adjunctive Therapy in Children with Partial Onset Seizures. This study is being done to test the safety of the study drug Lacosamide (LCM) syrup and how the body processes it.

FDA Food and Drug Administration - Index to Drug-Specific Information - This Index does not include all FDA approved drugs. It only includes drugs that have been the subject of a Healthcare Professional Information sheet, an Early Communication About an Ongoing Safety Review, or other important information. Please use Drugs@FDA to search for information on a drug not found in the Index.

National Council on Patient Information and Education NCPIE - One of the original patient safety coalitions, MCPIE works to advance the safe, appropriate use of medicines through enhanced communication

Builds safety beds for special needs children, youth and adults as well as handicapped, disabled and medically fragile individuals who need extra fall and entrapment protection while in bed.

Study is to evaluate the pharmacokinetics (blood levels), pharmacodynamics (how the drug acts on the body), and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in new borns and pre-term infants (less than 44 weeks of age).

The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.

The North American Clinical Trials Network (NACTN) is one more way that the Reeve Foundation is moving promising therapies from the lab to spinal cord injured patients. NACTN is working hard to insure that any clinical trial will be done in a way that maximizes both patient safety and our ability to gather valid, meaningful data. NACTN is an international network of hospitals with highly trained personnel and uniform protocols and data collection that help to ensure safety for all trial subjects and interpretable trial data

A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures

FDA is an agency within the Department of Health and Human Services1 and consists of centers and offices responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

Information on completed clinical trial conducted to assess the safety and efficacy of oral Glycopyrrolate Liquid in the management of problem drooling associated with cerebral palsy or other neurologic conditions in children

Information on ongoing study being sponsored by Medical College of Georgia to test the safety and effectiveness of cord blood infusion in children with motor disabilities due to cerebral palsy.

Study conducted and completed to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.

Purpose of this completed study is to provide additional information on safety and tolerability after multiple doses of pantoprazole in infants

The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole in infants

Future planned study with the objective of evaluating the relative merits, safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy.The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating gastroesophageal reflux.

Completed study assessed the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.