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A Translational Innovation Forum

A Translational Innovation Forum

IND Process and General Responsibilities under IND August 27, 2010 Kate Marusina, PhD, MBA Pav Aujla, MS, CCRP, RAC Primo N. Lara, Jr. MD. A Translational Innovation Forum. Definition of Drug and other helpful definitions 21 CFR 312 What is Regulatory Sponsor? Overview of IND process

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496 views • 35 slides
Investigational New Drug Application 21 CFR Part 312

Investigational New Drug Application 21 CFR Part 312

A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International gclasby@promedica-intl.com 714-799-1617 x 25. Investigational New Drug Application 21 CFR Part 312. IND Application About the Regulation.

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633 views • 30 slides
Richard Klein Office of Health and Constituent Affairs Food and Drug Administration

Richard Klein Office of Health and Constituent Affairs Food and Drug Administration

Expanded Access Programs for Drugs and Biologics _________________________________________________________. Richard Klein Office of Health and Constituent Affairs Food and Drug Administration. February 27, 2014. What is Expanded Access?. also called Treatment Use, Compassionate Use.

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380 views • 27 slides
Richard Klein Office of Health and Constituent Affairs Food and Drug Administration

Richard Klein Office of Health and Constituent Affairs Food and Drug Administration

Expanded Access Programs for Drugs and Biologics _________________________________________________________. Richard Klein Office of Health and Constituent Affairs Food and Drug Administration. February 27, 2014. What is Expanded Access?. also called Treatment Use, Compassionate Use.

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273 views • 27 slides

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