| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On February 26, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0021
|
| Skin Protectant Drugs for OTC Human Use
|
|
|
|
|
| 1978N-0021P
|
| Skin Protectant Drug Products for OTC Human Use
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
|
|
| 1996N-0417
|
| CGMP in Mfg. Packing or Holding Dietary Supplements
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
|
|
| 2001P-0239
|
| ANDA Suitability for Amlodipine 'Caplet'
|
|
|
|
|
| 2001P-0241
|
| ANDA Suitability for Paroxetine 'Caplet'
|
|
|
|
|
| 2002N-0204
|
| Bar Code Label Requirements for human drug products
|
|
|
|
|
| 2003D-0229
|
| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
|
|
|
|
|
| 2003D-0568
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| 2003N-0198
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Medicated Feed Mill License
|
|
|
|
|
| 2003N-0567
|
| Cardiovascular and Neurological Devices; Reclassification of Two Embolization Devices
|
|
|
|
|
| 2004N-0062
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
|
|
|
|
|
| 2004N-0077
|
| Agency Emergency Processing Under OMB Review; Animal Drug User Fee Cover Sheet
|
|
|
|
|
| 2004P-0091
|
| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
|
|
|
|
|
| 1978N-0021
|
| Skin Protectant Drugs for OTC Human Use
|
|
|
|
|
| PAV
1
|
| HFC-1 to The Cosmetic, Toiletry and Fragrance Association
|
| Vol #:
|
| 43
|
|
|
|
|
| 1978N-0021P
|
| Skin Protectant Drug Products for OTC Human Use
|
|
|
|
|
| PAV
1
|
| HFC-1 to The Cosmetic, Toiletry and Fragrance Association
|
| Vol #:
|
| 1
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
|
|
| EMC 1246
|
| Steve
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1247
|
| M. Morris
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1248
|
| B. Hernandez
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1249
|
| J. Stacey
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1250
|
| B. Peters
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1251
|
| V. Courtney
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1252
|
| A. Huey
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1253
|
| No signature
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1254
|
| T. Carr
|
| Vol #:
|
| 378
|
|
| | | | | | | | |
|
|
|
|
| EMC 5785
|
| Gordon Gacek
|
| Vol #:
|
| 789
|
|
|
|
|
| EMC 5786
|
| Tracey Smith
|
| Vol #:
|
| 789
|
|
|
|
|
| 2001P-0239
|
| ANDA Suitability for Amlodipine 'Caplet'
|
|
|
|
|
| WDL
1
|
| Cipher Pharmaceuticals Limited
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0241
|
| ANDA Suitability for Paroxetine 'Caplet'
|
|
|
|
|
| WDL
1
|
| Cipher Pharmaceuticals Limited
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002N-0204
|
| Bar Code Label Requirements for human drug products
|
|
|
|
|
| BKG 2
|
| Refs 1 - 31 found in 69FR9120
|
| Vol #:
|
| 19
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 19
|
|
|
|
|
| 2003D-0229
|
| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
|
|
|
|
|
| N
3
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0568
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices
|
|
|
|
|
| GDL
1
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| MO
4
|
| GCF-1
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0198
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Medicated Feed Mill License
|
|
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0567
|
| Cardiovascular and Neurological Devices; Reclassification of Two Embolization Devices
|
|
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0062
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0077
|
| Agency Emergency Processing Under OMB Review; Animal Drug User Fee Cover Sheet
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0091
|
| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
|
|
|
|
|
| ACK
1
|
| HFA-305 to Gastroparcsis & Dysmotilities Assn.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Gastroparcsis & Dysmotilities Assn.
|
| Vol #:
|
| 1
|
|
