Publications & Comments

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204 total entries

IQ Consortium Comments on M10 Bioanalytical Method Validation

Date of Publication: October 03, 2019

Agency: US Food & Drug Administration

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IQ Consortium Comments on Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Date of Publication: April 24, 2019

Agency: US Food & Drug Administration

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IQ 3Rs Benchmarking 2012 Survey: Strengths, Opportunities and Next Steps

Date of Publication: February 13, 2019

Author(s): AbbVie Inc., Alnylam Pharmaceuticals, Inc., Amgen, Astellas, AstraZeneca, Bayer Corporation, Baxter Healthcare Corporation, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Eisai, Eli Lilly, EMD Serono (Merck KGaA), Genentech, GlaxoSmithKline, Incyte, Ironwood Pharmaceuticals, Inc., Janssen (Johnson & Johnson), Merck, Mitsubishi Tanabe Pharma Corporation, Novartis, Pfizer, Pierre Fabre, Sanofi, Shire, Takeda, Theravance, UCB Pharma, Vertex

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IQ Consortium Comments on Docket No FDA-2018-D-4267. Biomarker Qualification: Evidentiary Framework

Date of Publication: February 08, 2019

Agency: US Food & Drug Administration

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IQ CPLG Preparing Comments Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability - Comments due 11 February 2019

Date of Publication: December 31, 2018

Docket # Docket ID:FDA-2018-D-4267 (https://www.regulations.gov/document?D=FDA-2018-D-4267-0001)

Agency: US Food and Drug Administration