Publications & Comments

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195 total entries

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IQ CPLG Preparing Comments Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability - Comments due 11 February 2019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IQ CPLG Comments on FDA Draft Guidance on Expansion Cohorts: Use in First-In-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry; Availability

Date of Publication: October 12, 2018

Docket # Docket Number: FDA-2018-D-2777 (https://www.regulations.gov/document?D=FDA-2018-D-2777-0007)

Agency: US Food and Drug Administration

IQ Comments on Framework for Assessing pH-Dependent Drug-Drug Interactions

Date of Publication: July 24, 2018

Docket # FDA-2018-N-1820 (https://www.regulations.gov/docket?D=FDA-2018-N-1820)

Agency: FDA

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IQ DPLG Pediatric Working Group Webinar: Container Closure and Device Systems for Pediatric Combination Products

Date of Publication: May 04, 2018

Author(s): Matthew S. Thomas, Eli Lilly and Company

Venue: Webinar

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