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Charging for Investigational Drugs Under an IND — Questions and Answers Guidance for Industry - PharmaFacts
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Charging for Investigational Drugs Under an IND — Questions and Answers Guidance for Industry

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Charging for Investigational Drugs Under an IND —

Questions and Answers Guidance for Industry

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

June 2016 Procedural

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Charging for Investigational Drugs Under an IND — Questions and Answers

Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information Center for Drug Evaluation and Research

Food and Drug Administration th 10001 New Hampshire Ave., Hillandale Bldg., 4

Floor

Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

and/or

Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

June 2016 Procedural

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I. II. III.

A. B. C. D.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 QUESTIONS AND ANSWERS....................................................................................... 2 General Questions .......................................................................................................................... 2 Charging in Clinical Trials ........................................................................................................... 3 Charging For Expanded Access Use ............................................................................................ 6 Cost Recovery Calculations .......................................................................................................... 7

CLICK HERE FOR FULL GUIDANCE