Publications & Comments
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203 total entries
IQ Consortium Comments on Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
IQ 3Rs Benchmarking 2012 Survey: Strengths, Opportunities and Next Steps
IQ Consortium Comments on Docket No FDA-2018-D-4267. Biomarker Qualification: Evidentiary Framework
IQ CPLG Preparing Comments Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability - Comments due 11 February 2019
IQ Consortium Comments on Docket No. FDA-2018-D-3292 Draft Guidance for Industry “Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics"