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20240329122006.0 |
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151010s1900 dcu o 000 0 eng d |
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|a EBLCP
|b eng
|e pn
|c EBLCP
|d OCLCQ
|d MERUC
|d OCLCQ
|d ZCU
|d ICG
|d OCLCO
|d OCLCF
|d OCLCQ
|d OCLCO
|d OCLCQ
|d OCLCO
|d LVT
|d DKC
|d AU@
|d OCLCQ
|d OCLCO
|d OCLCQ
|d OCLCO
|d OCLCQ
|d OCLCO
|d OCLCL
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|a 9780309585200
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|a 0309585201
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|a DEBBG
|b BV044107002
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|a (OCoLC)923262665
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|a n-us---
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|a RA395.A3 I
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|a 353.997
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|a UAMI
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|a Committees, Committee to Study the Use of Advisory.
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|a Food and Drug Administration Advisory Committees.
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|a Washington :
|b National Academies Press,
|c 1900.
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| 300 |
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|a 1 online resource (238 pages)
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| 336 |
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|a text
|b txt
|2 rdacontent
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|a computer
|b c
|2 rdamedia
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|a online resource
|b cr
|2 rdacarrier
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|a Print version record.
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|a ""Food and Drug Administration Advisory Committees""; ""Copyright""; ""Preface""; ""NOTES""; ""Acknowledgments""; ""Contents""; ""List of Abbreviations""; ""Summary""; ""The Roles of FDA Advisory Committees""; ""Practical Limits on Advisory Committees""; ""COMMITTEE MEMBERSHIP""; ""Nomination Criteria""; ""Recruitment Procedures""; ""Consumer Members""; ""Appointment Authority""; ""Administrative Responsibility for Appointments""; ""COMMITTEE INTEGRITY""; ""Options Requiring Legislation""; ""Options Available within Existing Authority""; ""COMMITTEE OPERATIONS""; ""Scheduling Meetings""
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| 505 |
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|a ""Meeting Preparation""""General Criteria for Setting the Agenda""; ""Setting Specific Agendas""; ""Timely Distribution of Materials""; ""Summaries of Materials Sent to Advisory Committees""; ""Use of Primary Reviewers""; ""Communications Issues""; ""Conducting an Advisory Committee Meeting""; ""Allocation and Control of Agenda Time""; ""Electronic Coverage of Meetings""; ""Voting""; ""Agency Neutrality""; ""Custom Tailoring of Committee Membership""; ""Meeting Follow-up""; ""ORGANIZATION AND MANAGEMENT""; ""System Management""; ""Compensation""; ""Orientation and Training""
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| 505 |
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|a ""AGENCY MANAGEMENT AND ACCOUNTABILITY""""Agency Management""; ""Agency Accountability""; ""A CONCLUDING RECOMMENDATION""; ""NOTES""; ""1 Introduction""; ""ORIGINS OF THE STUDY""; ""STUDY OBJECTIVES""; ""SCOPE OF THE STUDY""; ""THE ROLES OF FDA ADVISORY COMMITTEES""; ""PRACTICAL LIMITS ON THE USE OF ADVISORY COMMITTEES""; ""THE FEDERAL ADVISORY COMMITTEE ACT""; ""STUDY METHODS""; ""REPORT ORGANIZATION""; ""A NOTE ON CROSS-NATINOAL COMPARISONS""; ""APPENDIX""; ""NOTE""; ""2 Historical Evolution of FDA Advisory Committees""; ""DRUGS""; ""Drug Efficacy Study""; ""Over-the-Counter Drugs""
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| 505 |
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|a ""Prescription Drug Review""""Summary""; ""BIOLOGICS""; ""MEDICAL DEVICES""; ""The Cooper Report""; ""The Medical Device Amendments of 1976""; ""NIH STUDY SECTIONS""; ""SUMMARY""; ""NOTES""; ""3 The FDA Advisory Committee System""; ""THE PRODUCT EVALUATION PROCESS""; ""The Drug Evaluation Process""; ""The Biologics Approval Process""; ""The Device Approval Process""; ""AGENCY WORKLOAD AND ADVISORY COMMITTEES""; ""OFFICIAL PURPOSES OF ADVISORY COMMITTEES""; ""The FDA Regulations""; ""The NDA Rewrite""; ""Medical Device Statutes""; ""FDA Advisory Committee Charters""
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|a ""THE USES OF ADVISORY COMMITTEES""""Variations Among Centers""; ""Center Workload and Stage of Advisory Committee Use""; ""Other Means of Seeking Advice""; ""SUMMARY""; ""NOTES""; ""4 Recurring Issues""; ""MAJOR PRIOR REPORTS""; ""The Fountain Committee Report (1976)""; ""The Dorsen Committee Report (1977)""; ""The McMahon Commission Report (1982)""; ""The Lasagna Committee Report (1990)""; ""Other Reports""; ""THE GOLDFISH BOWL""; ""Congressional Oversight""; ""Media Coverage""; ""The Financial Community""; ""CONCLUSIONS""; ""NOTES""; ""5 Committee Membership""; ""NOMINATION CRITERIA""
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| 500 |
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|a ""General and Specific Criteria""
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| 590 |
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|a ProQuest Ebook Central
|b Ebook Central Academic Complete
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| 610 |
2 |
0 |
|a Institute of Medicine (U.S.).
|b Committee to Study the Use of Advisory Committees by the Food and Drug Administration.
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| 610 |
2 |
7 |
|a Institute of Medicine (U.S.).
|b Committee to Study the Use of Advisory Committees by the Food and Drug Administration
|2 fast
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| 650 |
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0 |
|a Public health advisory groups
|z United States
|x Evaluation.
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| 650 |
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6 |
|a Santé publique
|z États-Unis
|x Participation des citoyens
|x Évaluation.
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| 650 |
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7 |
|a Public health advisory groups
|x Evaluation
|2 fast
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| 651 |
|
7 |
|a United States
|2 fast
|1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq
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| 700 |
1 |
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|a Rettig, Richard A.
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| 700 |
1 |
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|a Earley, Laurence C.
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| 776 |
0 |
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|i Print version:
|a Committees, Committee to Study the Use of Advisory.
|t Food and Drug Administration Advisory Committees.
|d Washington : National Academies Press, ©1900
|z 9780309048378
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| 856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=3376294
|z Texto completo
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| 938 |
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|a ProQuest Ebook Central
|b EBLB
|n EBL3376294
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| 994 |
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|a 92
|b IZTAP
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