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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.

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IQ CPLG Preparing Comments Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability - Comments due 11 February 2019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IQ CPLG Comments on FDA Draft Guidance on Expansion Cohorts: Use in First-In-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry; Availability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