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Author : lindy-dunigan | Published Date : 2016-07-22
GUIDANCE FOR INDUSTRY Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New
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Contains Nonbinding Recommendations &#x/MCI; 1 ;&#x/MCI; 1 ;&#: Transcript
GUIDANCE FOR INDUSTRY Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or. fdagovCosmeticGuidances You may submit written comments regarding th is guidance at any time Submit written comments on the guidance to the Division of Dockets Management H FA305 Food and Drug Administration 5630 Fishers La ne rm 1061 Rockville MD 20 Free Float Restrictions Version 2 July 2015 FREE FLOAT 1.Free float restrictions include:Shares directly owned by State, Regional, Municipal and Local governments (excluding shares held by independent Contains Nonbinding Recommendations &#x/MCI; 0 ;&#x/MCI; 0 ;Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration Guidance for IndustryAdditional Draft to receive a copy of the guidance. Please use the document number (413) to identify the guidance you are requesting. Contains Nonbinding Recommendations Draft - Not for Implementation 1 Procedur Draft - Not for Implementation 2 Preface 38 39 40 Additional Copies 41 42 CDRH 43 Additional copies are available from the Internet . You may also send an e - mail request to 44 CDRH - Guidance@fd Table of Contents .............................................................................................................1 ...................................................................... Contains Nonbinding Recommendations 1 Information Sheet Guidance For IRBs, Clinical Investigators, and SponsorsThis guidance represents the Food and Drug Administration's (FDA's) current thinking Contains Nonbinding Recommendations &#x/MCI; 31; &#x/MCI; 31; Appendix 2: Additional Resources Ad Hoc Committee on Health Literacy for the Council on Scientific Affairs, American Medical Ass . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the Guidance for Industry and Food and Drug Administration Staff Document issued on June 21, 2016. This document will be in effect as of September 19, 2016.The draft of this document was issued on May 6, Contains Nonbinding Recommendations Drug-Induced Liver Injury: This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or c Contains Nonbinding Recommendations Draft – Not for Implementation What Is the Relationship Between Potency and Clinical Effectiveness for CGT RECOMMENDATIONS FOR POTENCY MEASUREMENTSHow to Det Contains Nonbinding Recommendations 1 &#x/MCI; 0 ;&#x/MCI; 0 ;Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance
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