U.S. Food and Drug Administration www.fda.gov NDA XX-XXX Dear : Please refer to your new drug applications submitted under section 505(b) of the Federal Food,
FDA Proposed Medication Guide: About Using Antidepressants in Children or Teenagers
U.S. Food and Drug Administration www.fda.gov FDA Proposed Medication Guide: About Using Antidepressants in Children or Teenagers The FDA has written a proposed Medication Guide
Congress Hammers FDA Over Handling of SSRIs
Jim Rosack Psychiatric News At press time, APA was waiting to hear whether the FDA would issue a black-box warning for pediatric use of SSRIs.
FDA Launches a Multi-Pronged Strategy to Strengthen Safeguards for Children Treated With Antidepressant Medications
FDA News The Food and Drug Administration (FDA) today issued a Public Health Advisory announcing a multi-pronged strategy to warn the public about the increased
Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
FDA Public Health Advisory U.S. Food and Drug Administration www.fda.gov Suicidality in Children and Adolescents Being Treated With Antidepressant Medications Today the Food and Drug