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| Dockets Entered
August 25, 2006
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0044
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| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| 2006N-0329
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application 21 CFR Part 515 - Extension
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 18061
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18062
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18063
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18064
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18065
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18066
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| Pure Encapsulations
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| Vol #:
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| 166
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| LET 18067
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| Nutrition Now Inc
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| Vol #:
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| 166
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| LET 18068
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18069
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18070
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18071
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18072
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| Integrative Therapeutics Inc
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| Vol #:
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| 166
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| LET 18073
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| New Centruy Company
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| Vol #:
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| 166
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| LET 18074
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| PuraPharm International LTD
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| Vol #:
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| 166
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| LET 18075
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| PuraPharm International LTD
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| Vol #:
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| 166
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| LET 18076
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| PuraPharm International LTD
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| Vol #:
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| 166
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| LET 18077
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| PuraPharm International LTD
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| Vol #:
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| 166
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| LET 18078
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| Nutrition Now Inc
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| Vol #:
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| 166
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| LET 18079
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| Magno-Humphries Inc
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| Vol #:
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| 166
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| LET 18080
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| Food Science Corporation
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| Vol #:
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| 166
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| LET 18081
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| Magno-Humphries, Inc
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| Vol #:
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| 166
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 18072
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| A. Weiland
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| Vol #:
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| 194
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| C 18073
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| B. Shew
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| Vol #:
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| 194
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| C 18074
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| D. Anna & W. Anna
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| Vol #:
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| 194
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| C 18075
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| A. Kirkpatrick
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| Vol #:
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| 194
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| EC 33264
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| Ms. Carol Collier
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| Vol #:
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| 142
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| EMC 3782
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| A. Karras
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| Vol #:
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| 195
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| EMC 3783
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| N. Johnson
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| Vol #:
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| 195
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| EMC 3784
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| M. McComb
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| Vol #:
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| 195
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| EMC 3785
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| J. Stefanucci
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| Vol #:
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| 195
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| EMC 3786
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| S. Minnes
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| Vol #:
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| 195
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| EMC 3787
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| S. Hill
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| Vol #:
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| 195
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| EMC 3788
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| J. Padilla
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| Vol #:
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| 195
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| EMC 3789
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| R. Sund
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| Vol #:
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| 195
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| EMC 3790
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| A. Gipson
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| Vol #:
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| 195
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| 2006D-0044
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| Guidance for Industry
on Patient-Reported Outcome Measures: Use in Medical Product Development
to Support Labeling Claims
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| EMC 6
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| A. Stone, PhD
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| Vol #:
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| 3
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| 2006D-0191
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| Guidance for Industry
and Food and Drug Administration; Guidance for the Use of Bayesian
Statistics in Medical Device Clinical Trials
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| EMC 1
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| Novartis Pharma AG
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| Vol #:
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| 2
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| EMC 2
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| No signature
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| Vol #:
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| 2
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| EMC 3
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| B. Carlin
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| Vol #:
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| 2
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| EMC 4
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| J Kadane
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| Vol #:
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| 2
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| EMC 5
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| H. Lopes
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| Vol #:
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| 2
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| EMC 6
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| S. Goodman, MD, MHS, PhD
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| Vol #:
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| 2
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| EMC 7
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| Frank
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| Vol #:
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| 2
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| EMC 8
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| C. Mehta and N. Patel
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| Vol #:
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| 2
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| EMC 9
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| Consulants in Toxicology
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| Vol #:
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| 2
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| EMC 10
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| Blue Cross and Blue Shield Association
(BCBSA) Technology Evaluation Center (TEC)
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| Vol #:
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| 2
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| EMC 11
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| Statisticians in the Pharmaceutical
Industry Limited
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| Vol #:
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| 2
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| 2006N-0329
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| Agency Information
Collection Activities; Proposed Collection; Comment Request; Medicated
Feed Mill License Application 21 CFR Part 515 - Extension
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| NEC 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0151
|
| Stay the current
approvable letter with conditions of any and all Premarket Applications
for silicone gel-filled breast implants
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|
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| EC 714
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| Miss. alexis moore
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| Vol #:
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| 3
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| EC 715
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| Mrs. Patricia McKeough
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| Vol #:
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| 3
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| 2006P-0223
|
| Switch
Plan B and equivalent EC drugs from prescription-only to OTC status
without age restrictions, exempt from prescription -dispensing requirement
any new drug eligible for filing an ANDA
|
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