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20240329122006.0 |
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151010s1999 dcu o 000 0 eng d |
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|a 697598701
|a 994397205
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|a 9780309597043
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|z (OCoLC)697598701
|z (OCoLC)994397205
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|a TX553.A3.E58 1999eb
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|a 363.192
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|a UAMI
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|a Staff, Institute of Medicine.
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|a Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies.
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| 260 |
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|a Washington :
|b National Academies Press,
|c 1999.
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| 300 |
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|a 1 online resource (158 pages)
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| 336 |
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
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|a Print version record.
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|a Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies -- Copyright -- PREFACE -- Contents -- WORKSHOP SUMMARY -- INTRODUCTION AND BACKGROUND -- OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES -- Food Additives -- GRAS SUBSTANCES -- Interim Additives -- LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS -- Flaws of the Current Review Process -- Proposed Changes in the Approval Process -- Change or Enforce Deadlines for Petition Reviews -- Implement User Fees -- Grant a Period of Market Exclusivity
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| 505 |
8 |
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|a Re-evaluate GRAS Affirmation ProcessEliminate Notice-and-Comment Procedures -- Abbreviate Review for Supplemental Uses -- Evaluate Use of Extramural Petition Review -- Prioritize Reviews -- Implement Safeguards to Prevent Sham Petitioning -- Establish a Sunset Period for Interim Additives -- Foster Improved Communication between Industry and FDA -- Improve Quality of Petitions Submitted to FDA -- SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS -- CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY -- CURRENT EFFORTS -- International Efforts
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| 505 |
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|a IMPROVING THE REGULATORY REVIEW PROCESSGovernment Perspective -- Industry Perspective -- Consumer Perspective -- SUMMARY -- APPENDIX A Legal Aspects of the Food Additive Approval Process -- HISTORY -- The Food, Drug, and Cosmetic Act of 1938 -- The Food Additives Amendment of 1958 -- DEFINITION OF FOOD ADDITIVE -- Components of Food -- Indirect Additives -- Dietary Supplements -- Generally Recognized as Safe -- APPROVAL PROCEDURES -- Food Additive Petitions -- GRAS Affirmation Petitions -- Interim Food Additives -- SAFETY STANDARDS
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| 505 |
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|a General Safety StandardCarcinogenicity and the Delaney Clause -- Special Restrictions: Labeling -- CASE STUDIES -- Artificial Sweeteners: Aspartame -- Biotechnology: Calgene's Tomato -- Novel Macroingredients: Olestra -- THE COMPOSITE PICTURE -- Track Records Compared -- A Catalogue of Proposed Solutions -- Internal Management Initiatives -- Statutory Hammers -- Prioritizing Reviews -- Imposing User Fees -- Extramural Reviews -- Combatting Sham Petitioning -- CONCLUSION -- APPENDIX: INTERNATIONAL COMPARISONS -- Canada -- The United Kingdom
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| 505 |
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|a The European UnionJapan -- REFERENCES -- APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug, � -- TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES -- Introduction -- Developments in Analytical Chemistry -- Developments in Toxicology -- The Emerging Understanding of Mechanisms -- Changes in Risk and Safety Assessment -- Changes in Agriculture -- Environmental Concerns -- Consumer Activity
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| 500 |
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|a ""Changes in Food Marketing and Consumption Trends""
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| 546 |
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|a English.
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| 590 |
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|a ProQuest Ebook Central
|b Ebook Central Academic Complete
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| 650 |
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0 |
|a Food additives
|z United States
|v Congresses.
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| 650 |
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0 |
|a Food additives
|x Safety regulations
|z United States
|v Congresses.
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| 650 |
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0 |
|a Food.
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| 650 |
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0 |
|a Social control.
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| 650 |
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0 |
|a Medical care.
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| 650 |
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0 |
|a Food additives.
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| 650 |
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0 |
|a Food law and legislation.
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| 650 |
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2 |
|a Legislation as Topic
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| 650 |
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2 |
|a Specialty Uses of Chemicals
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| 650 |
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2 |
|a Food
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| 650 |
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2 |
|a Social Control, Formal
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| 650 |
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2 |
|a Chemical Actions and Uses
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| 650 |
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2 |
|a Food and Beverages
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| 650 |
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2 |
|a Health Care Economics and Organizations
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| 650 |
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2 |
|a Technology, Industry, Agriculture
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| 650 |
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2 |
|a Chemicals and Drugs
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| 650 |
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2 |
|a Delivery of Health Care
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| 650 |
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2 |
|a Food Additives
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| 650 |
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2 |
|a Legislation, Food
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| 650 |
|
2 |
|a Patient Care
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| 650 |
|
6 |
|a Aliments
|x Additifs
|z États-Unis
|v Congrès.
|
| 650 |
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6 |
|a Aliments
|x Additifs
|x Sécurité
|x Règlements
|z États-Unis
|v Congrès.
|
| 650 |
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6 |
|a Aliments.
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| 650 |
|
6 |
|a Contrôle social.
|
| 650 |
|
6 |
|a Prestation de soins.
|
| 650 |
|
6 |
|a Aliments
|x Additifs.
|
| 650 |
|
6 |
|a Aliments
|x Droit
|v Législation.
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| 650 |
|
6 |
|a Soins médicaux.
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| 650 |
|
7 |
|a food.
|2 aat
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| 650 |
|
7 |
|a Social control
|2 fast
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| 650 |
|
7 |
|a Medical care
|2 fast
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| 650 |
|
7 |
|a Food law and legislation
|2 fast
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| 650 |
|
7 |
|a Food
|2 fast
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| 650 |
|
7 |
|a Food additives
|2 fast
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| 650 |
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|a Food additives
|x Safety regulations
|2 fast
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| 651 |
|
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|a United States
|2 fast
|1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq
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| 655 |
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|a Conference papers and proceedings
|2 fast
|
| 776 |
0 |
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|i Print version:
|a Staff, Institute of Medicine.
|t Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies.
|d Washington : National Academies Press, ©1900
|z 9780309064866
|
| 856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=3376712
|z Texto completo
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| 938 |
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|a EBL - Ebook Library
|b EBLB
|n EBL3376712
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| 994 |
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|a 92
|b IZTAP
|
