|
|
|
|
|
|
|
|
|
|
|
|
|
| Dockets Entered On November
10, 2005
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim
Notification Letters Dietary
|
|
|
| 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
|
|
|
| 2001D-0281
|
| Proposed Globally Harmonized
Alternative for PMA Procedures
|
|
|
| 2003N-0502
|
| Agency Information
Collection Activities; Proposed Collection; Comment Request; Study
to Measure the Compliance of Prescribers with the Contraindication
of the Use of bTriptansb in Migraine Headac
|
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods
and Cosmetics
|
|
|
| 2005D-0334
|
| Guidance for Industry on the
Pediatric Research Equity Act
|
|
|
| 2005D-0401
|
| Guidance for Industry
and FDA Staff: Compliance with Section 301 of the Medical Device User
Fee and Modernization Act of 2002, as amended Prominent and Conspicuous
Mark of Manufacturers on Single-Us
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion
of Regulated Medical Products; Part 15 Public Hearing
|
|
|
| 2005P-0267
|
| Remove from label for propofol
(Diprivan) the warning that propofol should be administered only by
trained persons
|
|
|
| 2005P-0366
|
| Classification of the Low Energy
Ultrasound Wound Cleaner
|
|
|
| 2005P-0452
|
| FDA's decisions concerning approvals
of generic versions of atorvastatin
|
|
|
| 2005P-0453
|
| FDA to establish tighter regulations
governing the process by which medical devices are reviewed and recalled
|
|
|
| 1997S-0162
|
| 30-Day Structure Function
Claim Notification Letters Dietary
|
|
|
| LET
16827
|
| Tabak's Health Products
|
| Vol #:
|
| 152
|
|
|
| LET
16828
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16829
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET 16830
|
| IdeaSphere Inc.
|
| Vol #:
|
| 151
|
|
|
| LET
16831
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16832
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16833
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16834
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16835
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16836
|
| IseaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16837
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16838
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16839
|
| IdeaSpkhere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16840
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16841
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16842
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16843
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16844
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
|
| LET
16845
|
| IdeaSphere Inc.
|
| Vol #:
|
| 152
|
|
| | | | | | | | |
|
|
| LET
16846
|
| Univera, Inc.,d.b.a. Oassis LifeSciences
|
| Vol #:
|
| 152
|
|
|
| LET
16847
|
| Hillestad Pharmaceuticals
|
| Vol #:
|
| 152
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| EMC 4233
|
| J. Maples
|
| Vol #:
|
| 515
|
|
|
| EMC 4234
|
| R. Glade
|
| Vol #:
|
| 515
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| EMC 616
|
| J. McCloskey
|
| Vol #:
|
| 21
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
| EMC 5850
|
| J. Maples
|
| Vol #:
|
| 789
|
|
|
| EMC 5851
|
| R. Glade
|
| Vol #:
|
| 789
|
|
|
| 2001D-0281
|
| Proposed Globally Harmonized Alternative for PMA Procedures
|
|
|
| GDL
4
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
| NAD
4
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003N-0502
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Study to Measure the Compliance of Prescribers with the Contraindication of the Use of bTriptansb in Migraine Headac
|
|
|
|
|
|
| BKG 2
|
| References 1 - 13
|
| Vol #:
|
| 1
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
| REF
2
|
| OMB Review for November 9, 2005
|
| Vol #:
|
| 17
|
|
|
| 2005D-0334
|
| Guidance for Industry on the Pediatric Research Equity Act
|
|
|
| EMC
1
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
|
| 2005D-0401
|
| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
|
|
|
|
|
|
|
| EMC
1
|
| Medical Device Manufacturers Association (MDMA)
|
| Vol #:
|
| 1
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
| EMC 55
|
| N. Lovejoy
|
| Vol #:
|
| 2
|
|
|
| EMC 56
|
| A. Woytowich
|
| Vol #:
|
| 2
|
|
|
| EMC 57
|
| S. Brown
|
| Vol #:
|
| 2
|
|
|
| EMC 58
|
| M. Lark
|
| Vol #:
|
| 2
|
|
|
| EMC 59
|
| J. Madore
|
| Vol #:
|
| 2
|
|
|
| EMC 60
|
| K. Jarpow
|
| Vol #:
|
| 2
|
|
|
| EMC 61
|
| J. Rhines
|
| Vol #:
|
| 2
|
|