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DOCKETS
MANAGEMENT |
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Dockets Entered On July 24, 2003
Table of Contents |
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Docket #
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Title
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1975N-0183H |
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Health-Care Antiseptic Drug
Products for OTC Human Use |
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2000N-1571 |
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Enrofloxacin for Poultry: Opportunity
for Hearing |
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2003D-0060 |
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Part11, Electronic records,
electronic signatures scope |
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2003D-0061 |
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Comparability Protocols Chemistry
Manufacturing and controls |
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2003D-0319 |
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Guidance for Industry and FDA
Staff; Draft; Premarket Assessment of Pediatric Medical Devices
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2003D-0334 |
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In Vitro Analytical Tests (IVATs):
Draft Guidance |
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2003P-0291
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Enforce the law and prevent
unlaw sale of contact lens |
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Details |
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1975N-0183H |
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Health-Care Antiseptic Drug
Products for OTC Human Use |
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ANS 3 |
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HFD-560 to Soap & Detergent
Association & CTFA |
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Vol #: |
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149 |
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SUP
9 |
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Alcavis International Inc
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Vol #: |
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149 |
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1990N-0135 |
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Mandatory Status of Nutrition
and Nutrient Content Revision |
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BKG 1 |
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Preliminary Regulatory Impact
Analysis |
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Vol #: |
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1 |
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BKG 3 |
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Background Material
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Vol #: |
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5 |
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BKG 4 |
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Background Material
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Vol #: |
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6 |
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2000N-1571 |
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Enrofloxacin for Poultry: Opportunity
for Hearing |
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TR 9 |
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Corrected April 28, 2003 Transcript
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Vol #: |
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381 |
Continued |
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2002N-0204 |
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Bar Code Label Requirements
for human drug products |
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EMC 204 |
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Boyd Anderson |
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Vol #: |
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17 |
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2002P-0317 |
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Recall Aspartame as a Neurotoxic
Drug |
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EMC 255 |
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Betty Martini |
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Vol #: |
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5 |
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EMC 256 |
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Betty Martini |
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Vol #: |
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6 |
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EMC 257 |
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Betty Martini |
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Vol #: |
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5 |
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EMC 258 |
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Charmaine B |
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Vol #: |
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5 |
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EMC 259 |
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Betty Martini |
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Vol #: |
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5 |
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EMC 260 |
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Betty Martini |
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Vol #: |
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5 |
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EMC 261 |
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Greg Miller |
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Vol #: |
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5 |
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2003D-0060 |
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Part11, Electronic records,
electronic signatures scope |
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EMC 18 |
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Computer Validation Initiatives
Committee of the Society of Quality Assurance |
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Vol #: |
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3 |
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2003D-0061 |
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Comparability Protocols Chemistry
Manufacturing and controls |
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C 12 |
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Bristol-Myers Squibb Pharmaceutical
Research Institute |
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Vol #: |
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1 |
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2003D-0319 |
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Guidance for Industry and FDA
Staff; Draft; Premarket Assessment of Pediatric Medical Devices
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GDL 1
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Guidance |
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Vol #: |
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1 |
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NAD 1
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FDA |
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Vol #: |
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1 |
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2003D-0334 |
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In Vitro Analytical Tests (IVATs):
Draft Guidance |
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GDL 1 |
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Baker & Daniels, Gen-Probe
Inc, Roche Diagnostics, Roche Molecular Diagnostics |
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Vol #: |
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1 |
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2003P-0291 |
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Enforce the law and prevent
unlaw sale of contact lens |
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C 7 |
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Mallinger and Eger Optometric
Associates |
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Vol #: |
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1 |
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C 8 |
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Jonathan L Warner OD
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Vol #: |
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1 |
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