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FDA CDER Regulatory Science: The Importance of Partnership and Consortia

Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research within the United States Food and Drug Administration,

November 15, 2017

Using Data to Reimagine Clinical Trials

April 11, 2017

Allowing Respondents to Skip Items During Electronic Collection of Patient-Reported Outcome (PRO) Data: Does It Matter?

April 11, 2017

Evaluating the Conceptual Equivalence Between Paper and Three Electronic Data Collection Modes of the EQ-5D-5L Health Status Instrument

FDA qualification of intracranial adjusted hippocampal volumetric magnetic resonance imaging (ICV-HV vMRI) as a prognostic biomarker for pre-dementia clinical trials for Alzheimer disease therapeutics

Conrado, D.J., et al.; “FDA qualification of intracranial adjusted hippocampal volumetric magnetic resonance imaging (ICV-HV vMR

Informed consent ensuring access to anonymized patient-level data and biospecimen is critical to accelerating innovative Alzheimer disease treatments

Arnerić, S.P., et al.; “Informed consent ensuring access to anonymized patient-level data and biospecimen is critical to accele

Concise Informed Consent to Enable Data and Sample Access to Advance Treatments

October 26, 2017

226th ENMC International Workshop: Towards Validated and Qualified Biomarkers for Therapy Development for Duchenne Muscular Dystrophy

US FDA Awards I-ACT for Children a Grant for Pediatric Medicines and Devices Network

October 24, 2017

Accelerating the Clinical Trial Process in Duchenne

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