| Safety of COVID-19 Vaccination in US Children Ages 5-11 Years. | Pediatrics | 2022 |
| How can we quantify and compare harm in surgical trials? | American Journal of Ophthalmology | 2022 |
| The Pitfalls of Abnormal Laboratory Value Interpretation in Vaccine Clinical Trials: The Example of Asymptomatic Transient Neutropenia. | Drugs in R and D | 2021 |
| Considerations for the Use of Phage Therapy in Clinical Practice. | Antimicrobial Agents and Chemotherapy | 2022 |
| REGULATIONS AND PHARMACOVIGILANCE | | 2009 |
| Adverse Reactions Associated With Cannabis Consumption as Evident From Search Engine Queries | JMIR Public Health and Surveillance | 2017 |
| Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial | Southern Medical Journal | 2018 |
| Botulinum Toxin Injection | Current Clinical Urology | 2017 |
| Safety of calcitonin stimulation tests with calcium | Hormones | 2021 |
| Neuroimmunological adverse events associated with immune checkpoint inhibitor: a retrospective, pharmacovigilance study using FAERS database | Journal of Neuro-Oncology | 2021 |
| Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate (EBC-46) | Journal of Veterinary Internal Medicine | 2021 |
| Regenerative Cell-Based Therapies: Cutting Edge, Bleeding Edge, and Off the Edge | Regenerative Engineering and Translational Medicine | 2020 |
| Biologics for chronic rhinosinusitis | The Cochrane Library | 2020 |
| Safety and efficacy of autologous tumour cell vaccines as a cancer therapeutic to treat solid tumours and haematological malignancies: a meta-analysis protocol for two systematic reviews | BMJ Open | 2020 |
| Biologics for chronic rhinosinusitis | The Cochrane Library | 2019 |
| Transjugular Intrahepatic Portosystemic Shunt does not affect the efficacy and safety of direct-acting antivirals in patients with advanced cirrhosis: A real-life, case-control study | Digestive and Liver Disease | 2019 |
| Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA | BMC Bioinformatics | 2019 |
| Outcomes of Bedaquiline Treatment in Patients with Multidrug-Resistant Tuberculosis | Emerging Infectious Diseases | 2019 |
| Transplantation and diabetes (Transdiab): a pilot randomised controlled trial of metformin in impaired glucose tolerance after kidney transplantation | BMC Nephrology | 2019 |
| Interventions for maintenance of surgically induced remission in Crohn's disease: a network meta-analysis | The Cochrane Library | 2019 |
| Factors Associated With Complete Remission After Rituximab Therapy for Pemphigus | JAMA Dermatology | 2019 |
| Comparative Effectiveness of Combining MTX with Biologic Drug Therapy Versus Either MTX or Biologics Alone for Early Rheumatoid Arthritis in Adults: a Systematic Review and Network Meta-analysis | Journal of General Internal Medicine | 2019 |
| Immunogenicity and reactogenicity of high- vs. standard-dose trivalent inactivated influenza vaccine in healthcare workers: a pilot randomized controlled trial | Clinical Microbiology and Infection | 2019 |
| Research Deviations in FDA-Regulated Clinical Trials: A Cross-Sectional Analysis of FDA Inspection Citations | Therapeutic Innovation and Regulatory Science | 2018 |
| Emergency Department Discharge of Pulmonary Embolus Patients | Academic Emergency Medicine | 2018 |
| Pharmacovigilance in Crisis: Drug Safety at a Crossroads | Clinical Therapeutics | 2018 |
| Improving multiple sclerosis management and collecting safety information in the real world: the MSDS3D software approach | Expert Opinion on Drug Safety | 2018 |
| The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry: design, rationale, and characteristics of patients enrolled in the first 12 months | Pediatric Rheumatology | 2017 |
| Ribavirin for treating Crimean Congo haemorrhagic fever | The Cochrane Library | 2017 |
| Effect of Current Dietary Recommendations on Weight Loss and Cardiovascular Risk Factors | Journal of the American College of Cardiology | 2017 |
| Safety and Durability of RBX2660 (Microbiota Suspension) for Recurrent Clostridium difficile Infection: Results of the PUNCH CD Study | Clinical Infectious Diseases | 2016 |
| Safety and Effectiveness of Arginine in Adults | Journal of Nutrition | 2016 |
| A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer | Clinical Pharmacology and Therapeutics | 2016 |
| Phase 1 dose de-escalation trial of the endogenous folate [6R]-5,10-methylene tetrahydrofolate in combination with fixed-dose pemetrexed as neoadjuvant therapy in patients with resectable rectal cancer | Investigational New Drugs | 2015 |
| Serious adverse events during a 6-min walk test in patients with pulmonary hypertension | European Respiratory Journal | 2015 |
| Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study | Pharmacotherapy | 2015 |
| Adverse Events in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Arthritis and Rheumatology | 2015 |
| Prevalence of adverse events to radiopharmaceuticals from 2007 to 2011 | Journal of Nuclear Medicine | 2014 |
| Incidence of adverse events after high doses of onabotulinumtoxinA for multiple indications | Urology | 2014 |
| Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND | Therapeutic Innovation and Regulatory Science | 2014 |
| The need for expanded monitoring of adverse events in behavioral health clinical trials | Contemporary Clinical Trials | 2013 |
| Randomized controlled trials: what are they and who needs them? | Periodontology 2000 | 2012 |
| Clinical trial nurse's role in safety reporting | Nursing Forum | 2012 |
| Appendix 3: Another Look at the US IND Annual Report | | 2012 |
| Pharmacovigilance for clinical trials in India: Current practice and areas for reform | Perspectives in Clinical Research | 2011 |
| Evaluation of a new heparin agent in percutaneous coronary intervention: results of the phase 2 evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) Trial | Circulation | 2010 |
| Technical challenges in designing post-marketing eCRFs to address clinical safety and pharmacovigilance needs | Contemporary Clinical Trials | 2010 |
