FDA Warns Against Use of Unapproved Medical Devices to Help Assess or Diagnose a Concussion
April 10th 2019The FDA warned that such tools, including mobile apps marketed to coaches or parents for use during sporting events, have not been reviewed by the agency for safety and efficacy and could result in an incorrect diagnosis.
FDA: NDA for Diabetic Gastroparesis Treatment Rejected in Current Form
April 3rd 2019The FDA will not issue a new drug application (NDA) for the recurrent diabetic gastroparesis medication Gimoti in the application's present form, but they have issued recommendations to address the 2 remaining approvability issues, related to clinical pharmacoogy and product quality, in the NDA resubmission.
Possible Link Between Seizure and E-Cigarette Use Under FDA Investigation
April 3rd 2019According to the FDA, seizures are known potential adverse effects of nicotine poisoning and have been reported in scientific literature in relation to intentional or accidental swallowing of nicotine-containing e-liquids.
First Drug Therapy for PostPartum Depression Receives FDA Approval
March 20th 2019Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement that the approval provides an important new treatment option for PPD.
Providing Care for Children With Headache
March 19th 2019In a session presented at the National Association of Pediatric Nurse Practitioners national conference in New Orleans, Elizabeth Rende, DNP, CPNPâ€PC, PMHSâ€BC, FAAN with Duke Pediatric Neurology said up to 85% of pediatric patients have had a significant headache event by age 15 years.
Developments in Oral Chemotherapy Allows Patients to Live Full Lives
March 16th 2019In this clip from the National Community Oncology Dispensing Association, Daphne Duvall Meyer, RN, OCN, a Nurse Manager at Postchartrain Cancer Center, explains how advancements in oral chemotherapy improve the quality of patient's lives.
Menstruation: A Vital Tool for Assessing Health in Females
March 9th 2019At the 40th National Conference of the National Association of Pediatric Nurse Practitioners, in New Orleans, experts presenting a session on menstrual management said that amenorrhea and heavy menstrual bleeding (HMB) can both indicate a variety of medical issues in the pediatric patient population.