| | | | | | | | | | |
|
|
| Dockets Entered
On October 2, 2006
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1976N-0052N
|
| OTC Nasal Decongestants
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
| 2001D-0475
|
| Providing Regulatory Submissions in Electronic Format-ANDA's
|
|
|
| 2003D-0364
|
| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs
|
|
|
| 2004P-0157
|
| ANDA Suitability for Amoxicillin and Clavulanate Potassium Tablets for Oral Suspension 200 mg/28.5 mg and 400 mg/57 mg
|
|
|
| 2006D-0275
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems
|
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
| 2006N-0283
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
|
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
|
|
| 2006P-0402
|
| FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)
|
|
|
| 2006V-0401
|
| Laser Display Device
|
|
|
| 1976N-0052N
|
| OTC Nasal Decongestants
|
|
|
| SUP 10
|
| Robinson & Cole, LLP
|
| Vol #:
|
| 105
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
| SUP 9
|
| Robinson & Cole, LLP
|
| Vol #:
|
| 116
|
|
|
| 2001D-0475
|
| Providing Regulatory Submissions in Electronic Format-ANDA's
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003D-0364
|
| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004P-0157
|
| ANDA Suitability for Amoxicillin and Clavulanate Potassium Tablets for Oral Suspension 200 mg/28.5 mg and 400 mg/57 mg
|
|
|
| PAV 1
|
| FDA/CDER to The Weinberg Group Inc.
|
| Vol #:
|
| 2
|
|
|
| 2006D-0275
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems
|
|
|
| EC 1
|
| Mrs. Alpha Anderson
|
| Vol #:
|
| 1
|
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
| C 9
|
| A. Rhodes
|
| Vol #:
|
| 1
|
|
|
| 2006N-0283
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
|
|
|
|
|
|
| C 3
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
|
| | | | | | | | |
|
|
| EC 66
|
| Mrs. Nancy Hokkanen
|
| Vol #:
|
| 3
|
|
|
| EC 67
|
| Mrs. Priscilla Lorentzen
|
| Vol #:
|
| 3
|
|
|
| EC 68
|
| Mrs. Debra Kaiser
|
| Vol #:
|
| 3
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
| AMD 1
|
| Chemically Associated Neurological Disorders
|
| Vol #:
|
| 1
|
|
|
| EC 727
|
| Mrs. Pamela Morrell
|
| Vol #:
|
| 3
|
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
|
|
| RC 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2006P-0402
|
| FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)
|
|
|
| ACK 1
|
| FDA/DDM to Washington Legal Foundation (WLF)
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Washington Legal Foundation (WLF)
|
| Vol #:
|
| 1
|
|
|
| 2006V-0401
|
| Laser Display Device
|
|
|
| ACK 1
|
| FDA / DDM to Superimaging Inc and AP Marketing Development
|
| Vol #:
|
| 1
|
|
|
| ACK 2
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
| VAR 1
|
| Superimaging Inc and AP Marketing Development
|
| Vol #:
|
| 1
|
|