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Drug Safety in Pregnancy Satisfy Regulatory Requirements With Help From Our Perinatal Pharmacoepidemiology Research Team The safety of medical products when used in pregnancy is often not well characterized at the time of marketing authorization unless …
Assigning Treatment Strategy Using Real-World Data A Challenge of Real World Data: How to Assign Individuals to a Treatment Strategy When Their Data Are Consistent With Several Treatment Strategies at Baseline Garcia-Albeniz X , Hsu J, Hernan MA …
Longitudinal Modeling Approaches to Assess Association Between Two Clinical Outcomes Assessments Bintu Sherif, MS Director, Biostatistics Transcript With an increased regulatory focus on incorporating patient perspectives in drug development, …
Effects of Continuous Use of Antidepressants on Dementia The effect of continuous use of antidepressants, with or without anticholinergic properties, for at least 4 months versus no treatment on the incidence of dementia: a target trial emulation. Forns …
JCA Strategy and Planning The launch of Joint Clinical Assessments in 2025 represents a significant change to the marketing authorization process in the EU. It is critical that drug and device developers become informed on the latest guidance to be …
How are United States ICER'S Evidence Ratings Determined? You can read the related research here: How are United States ICER'S evidence ratings determined?: A systematic review of ICER'S evidence ratings in evidence reports for new drugs in 2020 and 2021. …
Differences and Similarities of Health Economic Evaluation for Medical Technologies by HTA Bodies Vijay D'Souza, PhD Senior Associate, Market Access and Outcomes Strategy Transcript In recent years, an increasing number of medical technologies such as …
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Identifying an Appropriate Drug for Comparative Safety Research Antiepileptic Drugs in Pregnancy: Searching for a Reference Drug for Comparative Safety AV Margulis , AS Oberg, S Hernandez-Diaz. Poster presented at the 33rd International Conference on …
2020 FDA Patient-Reported Outcomes Guidance Draft On August 31, 2020, the FDA released its draft guidance titled “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” …