Drug Labeling

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  Subject Areas on Research

  • ALSUntangled (ALSU): a scientific approach to off-label treatment options for people with ALS using tweets and twitters. 
  • Adding pharmacogenetics information to drug labels: lessons learned. 
  • Antidepressant Regulatory Warnings, Prescription Patterns, Suicidality and Other Aggressive Behaviors in Major Depressive Disorder and Anxiety Disorders. 
  • Antidepressants in pregnancy: a review of commonly prescribed medications. 
  • Balancing the benefits and risks of inhaled long-acting beta-agonists--the influence of values. 
  • Bleeding After Musculoskeletal Surgery in Hospitals That Switched From Hydroxyethyl Starch to Albumin Following a Food and Drug Administration Warning. 
  • Building gold standard corpora for medical natural language processing tasks. 
  • Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs. 
  • Clinical Approach to Cardiovascular Toxicity of Oral Antineoplastic Agents: JACC State-of-the-Art Review. 
  • Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). 
  • Communicating quantitative risks and benefits in promotional prescription drug labeling or print advertising. 
  • Congress, the FDA, and the fair development of new medications for children. 
  • DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans. 
  • Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial. 
  • Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier. 
  • Drug labeling and exposure in neonates. 
  • Factors associated with off-label use of drug-eluting stents in patients with ST-elevation myocardial infarction. 
  • Food and drug administration black box warning on the perioperative use of droperidol: a review of the cases. 
  • Genetic predisposition of life-threatening antiepileptic-induced skin reactions. 
  • Haloperidol for postoperative nausea and vomiting: are we reinventing the wheel? 
  • Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication. 
  • Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals. 
  • Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy. 
  • Influence of Kidney Function Estimation Methods on Eligibility for Edoxaban Population Impact of the US Food and Drug Administration's Approach for Its Product Labeling. 
  • Initial experience with teriparatide in the United States. 
  • Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs. 
  • Mechanisms to provide safe and effective drugs for children. 
  • Medication dispensing errors and potential adverse drug events before and after implementing bar code technology in the pharmacy. 
  • New drug application strategies for supraventricular arrhythmias. 
  • Package insert: view of a rural town practitioner. 
  • Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database. 
  • Parental misinterpretations of over-the-counter pediatric cough and cold medication labels. 
  • Patient receipt and understanding of written information provided with isotretinoin and estrogen prescriptions. 
  • Peer-reviewed publication of clinical trials completed for pediatric exclusivity. 
  • Potential Implications of Expanded US Food and Drug Administration Labeling for Sacubitril/Valsartan in the US. 
  • Potential use of auxiliary labels to promote patient awareness of pharmacogenetic testing. 
  • Pro: The Food and Drug Administration Black box warning on droperidol is not justified. 
  • Readability of ocular medication inserts. 
  • Report from the 100th Cardiovascular and Renal Drugs Advisory Committee meeting: US Food and Drug Administration: December 8-9, 2003 Gaithersburg, MD. 
  • Safety and transparency of pediatric drug trials. 
  • Safety monitoring of drugs receiving pediatric marketing exclusivity. 
  • Surfactant Administration in Preterm Infants: Drug Development Opportunities. 
  • Systematic review: reliability of compendia methods for off-label oncology indications. 
  • The Need for Pediatric Drug Development. 
  • The new FDA labeling rule: impact on prescribing rheumatological medications during pregnancy. 
  • The possible harms of statins: What do product labels, patient package inserts, and pharmacy leaflets tell us? 
  • The use of droperidol before and after the Food and Drug Administration black box warning: a survey of the members of the Society of Ambulatory Anesthesia. 
  • What should work, may not. 
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  Keywords of People

  • Cohen-Wolkowiez, Michael, Kiser-Arena Distinguished Professor, Pediatrics, Infectious Diseases