A Treatise on the Law of Foods, Drugs, and Cosmetics, Volume 4W. H. Anderson Company, 1963 - 2196 pages |
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Page 1397
... reports of clinical studies will not be regarded as adequate unless they in- clude reports from more than one independent , competent investigator who maintain adequate case histories of an adequate number of subjects , designed to ...
... reports of clinical studies will not be regarded as adequate unless they in- clude reports from more than one independent , competent investigator who maintain adequate case histories of an adequate number of subjects , designed to ...
Page 1905
... reports of investigations that have been made to show whether or not the drug is safe for use and effective in use . a . An application may be refused unless it contains full reports of adequate tests by all methods reasonably ...
... reports of investigations that have been made to show whether or not the drug is safe for use and effective in use . a . An application may be refused unless it contains full reports of adequate tests by all methods reasonably ...
Page 1914
... reports concerning any information of the following kinds : ( i ) Information concerning any un- expected side effect , injury , toxicity , or sensitivity reaction or any unexpected incidence or severity thereof associ- ated with ...
... reports concerning any information of the following kinds : ( i ) Information concerning any un- expected side effect , injury , toxicity , or sensitivity reaction or any unexpected incidence or severity thereof associ- ated with ...
Contents
VOLUME ONE PREFACE iii | 1466 |
APPENDIX | 1469 |
EXEMPTIONS IN CASE OF DRUGS AND DEVICESREGULATION FOR GOODS TO BE PROCESSED LABELED OR REPACKED ELSEWHERE | 1494 |
Copyright | |
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accordance added adequate adulterated agency amended animals appear application appropriate approved authorized batch bears cause certification cheese chemical color additive commerce Commission Commissioner Congress contains Cosmetic Act court deemed delivery Department designated determine device directions District Drug Administration effect enacted establishment evidence examination exemption Federal Food filing finds Food and Drug foreign hearing identity imported ingredients inspection intended Internal Revenue Code interstate issued June labeling less manufacture means meat ment methods milk narcotic drug necessary notice officer otherwise package paragraph penicillin permit person petition poultry preparation prescribed prevent proceedings processing proposed Public Law pursuant quantity reasonable records regulations relating reports Representatives request respect sample Secretary Secretary of Agriculture Session shipment specified standard Stat statement submitted subsection substance term tests thereof tion tolerance United unless violation