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| Dockets Entered
On September 25, 2006
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| Docket #
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| Title
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| 2006E-0031
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| Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0283
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0335
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| Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of
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| 2006N-0381
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
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| 2006O-0232
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
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| 2006P-0135
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| Issue Guidance to Industry outlining procedures and standards for initiating an 'expanded access program' for unapproved drugs
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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-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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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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| 2006P-0392
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| ANDA for a Diazepam Rectal Gel that Relies on Diastat 5 mg/mL, 10 mg/2mL, 15 mg/3 mL or 20 mg/mL
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EC 517
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| Mrs. gwen shakir
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| Vol #:
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| 17
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| 1
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| EC 12
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| Ms. Miranda Hinds
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| Vol #:
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| 1
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| 2006E-0031
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| Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
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| N 1
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| FDA
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| 1
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| EC 9
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| ASECO
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| Vol #:
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| 1
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| 2006N-0283
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
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| EC 1
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| Eli Lilly and Company
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0335
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| Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of
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| NFR 1
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| FDA
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| Vol #:
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| 1
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| NPR 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0381
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
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| N 1
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| FDA
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| Vol #:
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| 1
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2006O-0232
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
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| SUP 1
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| Boehringer Ingelheim (BI)
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| Vol #:
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| 2
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| 2006P-0135
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| Issue Guidance to Industry outlining procedures and standards for initiating an 'expanded access program' for unapproved drugs
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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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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| EC 723
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| n/a
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| Vol #:
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| 3
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| C 3
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| Valeant Pharmaceuticals International (Valeant)
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| Vol #:
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| 1
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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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| EC 708
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| Ms. Tonya Wilson
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| Vol #:
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| 5
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| 2006P-0392
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| ANDA for a Diazepam Rectal Gel that Relies on Diastat 5 mg/mL, 10 mg/2mL, 15 mg/3 mL or 20 mg/mL
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| ACK 1
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| FDA/DDM to Valeant Pharmaceuticals International (Valeant)
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| Vol #:
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| 1
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| CP 1
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| Valeant Pharmaceuticals International (Valeant)
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| Vol #:
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| 1
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