|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dockets Entered On July 2, 2003
Table of Contents |
|
|
Docket #
|
|
Title
|
|
|
1995N-0309
|
|
CGMPs for the Production of
Infant Formula |
|
|
1999D-1738
|
|
Bioavilability & Bioequivalence
Studies for Nasal Aerosols |
|
|
2001D-0368
|
|
Submitting Marketing Applications
according to ICH/CTD Forma |
|
|
2002P-0413
|
|
Health Claim: Phosphatidylserine
and cognitive dysfunction |
|
|
2003N-0056
|
|
Patient Examination & Surgeons'
Gloves; Test Procedures |
|
Contents |
|
1995N-0309
|
|
CGMPs
for the Production of Infant Formula |
|
|
C 19 |
|
Center for Science in the Public
Interest (CSPI) |
|
Vol #: |
|
9 |
Attachment 1,
2 |
|
|
NEC 3
|
|
FDA |
|
Vol #: |
|
1 |
|
|
|
1996N-0417 |
|
CGMP in Mfg. Packing or Holding
Dietary Supplements |
|
|
|
|
|
C 127 |
|
Michael T. Chang |
|
Vol #: |
|
17 |
|
|
|
1999D-1738
|
|
Bioavilability
& Bioequivalence Studies for Nasal Aerosols |
|
|
C 20 |
|
Novex Pharma |
|
Vol #: |
|
2 |
|
|
|
EMC 1 |
|
GlaxoSmithKline |
|
Vol #: |
|
1 |
Attachment |
|
|
2000D-1598 |
|
Voluntary Labeling for Bioengineered
Foods |
|
|
|
|
|
C 9853 |
|
Tamara Tuthill |
|
Vol #: |
|
572 |
|
|
|
C 9854 |
|
Gerald Theisen |
|
Vol #: |
|
572 |
|
|
|
C 9855 |
|
John Harmon |
|
Vol #: |
|
572 |
|
|
|
C 9856 |
|
Sylvia Forbes |
|
Vol #: |
|
572 |
|
|
|
C 9857 |
|
Joanne Steele |
|
Vol #: |
|
572 |
|
|
|
C 9858 |
|
Noel C. Nelson |
|
Vol #: |
|
572 |
|
|
|
C 9859 |
|
Lora Nell Davidson |
|
Vol #: |
|
572 |
|
|
|
C 9860 |
|
Melinda S. Morton |
|
Vol #: |
|
572 |
|
|
|
C 9861 |
|
Phillip Robert Miner
|
|
Vol #: |
|
572 |
|
|
|
C 9862 |
|
Nancy Draper |
|
Vol #: |
|
572 |
|
|
|
C 9863 |
|
Vicke Leeds |
|
Vol #: |
|
572 |
|
|
|
C 9864 |
|
Jerry R. Williams |
|
Vol #: |
|
572 |
|
|
|
C 9865 |
|
Jessica Williams |
|
Vol #: |
|
572 |
|
|
|
C 9866 |
|
Nancy Morris |
|
Vol #: |
|
572 |
|
|
|
|
|
|
|
|
|
|
|
|
|
C 9867 |
|
Mamie Mary Hunt |
|
Vol #: |
|
572 |
|
|
|
C 9868 |
|
Delilah Smith |
|
Vol #: |
|
572 |
|
|
|
C 9869 |
|
Ronald Harris |
|
Vol #: |
|
572 |
|
|
|
C 9870 |
|
Marian Vimont |
|
Vol #: |
|
572 |
|
|
|
C 9871 |
|
Earl C. Brydon |
|
Vol #: |
|
572 |
|
|
|
C 9872 |
|
Margie M. Epp |
|
Vol #: |
|
572 |
|
|
|
C 9873 |
|
Frank Miller |
|
Vol #: |
|
572 |
|
|
|
C 9874 |
|
Melinda S. Morton |
|
Vol #: |
|
572 |
|
|
|
C 9875 |
|
Shirley Bowman |
|
Vol #: |
|
572 |
|
|
|
2001D-0368
|
|
Submitting
Marketing Applications according to ICH/CTD Forma |
|
|
C 9 |
|
Jerussi Consulting, Inc.
|
|
Vol #: |
|
1 |
|
|
|
C 10 |
|
Baxter Healthcare Corporation
(Baxter) |
|
Vol #: |
|
1 |
|
|
|
2002P-0413
|
|
Health
Claim: Phosphatidylserine and cognitive dysfunction |
|
|
ACK 1 |
|
HFS-800 to Emord & Associates,
PC |
|
Vol #: |
|
6 |
|
|
|
ANS 1 |
|
HFS-800 to Emord and Associates
for Dr. K Smith |
|
Vol #: |
|
7 |
|
|
|
LET 6 |
|
Dr. Kyle Smith |
|
Vol #: |
|
6 |
|
|
|
2003D-0118 |
|
Decorative Contact Lens (Import
alert #86-10) |
|
|
|
|
|
C 31 |
|
Erica A. Hacker, O.D.
|
|
Vol #: |
|
1 |
|
|
|
C 32 |
|
Thomas Flickinger, O.D., PhD
|
|
Vol #: |
|
1 |
|
|
|
C 33 |
|
William J. Lindahl, O.D.
|
|
Vol #: |
|
1 |
|
|
|
C 34 |
|
Mark R. Flora, O.D.
|
|
Vol #: |
|
1 |
|
|
|
C 35 |
|
Valley Eye Care, PC
|
|
Vol #: |
|
1 |
|
|
|
2003N-0056
|
|
Patient
Examination & Surgeons' Gloves; Test Procedures |
|
|
C 2 |
|
American Dental Assn (ADA)
|
|
Vol #: |
|
1 |
|
|
|
C 3 |
|
Thai Rubber Glove Manufacturers
Association |
|
Vol #: |
|
1 |
|
|
|
C 4 |
|
JM Gloves Co., Ltd.
|
|
Vol #: |
|
1 |
|
|
|
2003P-0270 |
|
Prohibit False and Misleading
Labeling |
|
|
|
|
|
C 10 |
|
Rita Flygar |
|
Vol #: |
|
1 |
|
|
|
C 11 |
|
Ryan R. Anderson |
|
Vol #: |
|
1 |
|
|
|
C 12 |
|
Ursula Pelka |
|
Vol #: |
|
1 |
|
|
|
C 13 |
|
Joan Armer, RN |
|
Vol #: |
|
1 |
|
|
|
C 14 |
|
Julie Eyrich |
|
Vol #: |
|
1 |
|
|
|
2003P-0291 |
Enforce the law and prevent
unlaw sale of contact lens |
|
C 1 |
|
Michael M. Judkins, O.D.
|
|
Vol #: |
|
1 |
|
|
|
C 2 |
|
W. Edward Culbertson, O.D.
|
|
Vol #: |
|
1 |
|
|
|
C 3 |
|
Thomas C. Mueller, O.D.
|
|
Vol #: |
|
1 |
|
Page Created July 3, 2003 jb |