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Publications & Comments

Search for publications, comments, and IQ presentations using the search bar on the left side of the page, or view recent publications, comments, and presentations by scrolling through the list below.

203 total entries

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IQ CPLG Preparing Comments Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability - Comments due 11 February 2019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

IQ Consortium Comments on Docket No. FDA-2018-D-3292 Draft Guidance for Industry “Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics"

Date of Publication: December 13, 2018

Agency: US Food & Drug Administration

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