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Dockets Entered On July 1,
2003
Table
of Contents |
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Docket #
|
|
Title
|
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|
1995N-0309
|
|
CGMPs for the Production of
Infant Formula |
|
|
2002D-0526
|
|
Guidance for drug Chemistry,
Manufacturing, Control Info. |
|
|
2003D-0061
|
|
Comparability Protocols Chemistry
Manufacturing and controls |
|
Contents |
|
1978N-0036D |
|
OTC antidiarrheal |
|
|
|
|
|
NCR 1
|
|
FDA |
|
Vol #: |
|
34 |
|
|
|
1995N-0309
|
|
CGMPs
for the Production of Infant Formula |
|
|
C 17 |
|
Marsha Walker,RN,IBCLC
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|
Vol #: |
|
9 |
|
|
|
C 18 |
|
Florida Department of Health
|
|
Vol #: |
|
9 |
|
|
|
1996N-0417 |
|
CGMP in Mfg. Packing or Holding
Dietary Supplements |
|
|
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|
C 125 |
|
B. Bryant |
|
Vol #: |
|
17 |
|
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|
C 126 |
|
Sharon D. Keeler |
|
Vol #: |
|
17 |
|
|
|
1998P-0151 |
|
Introduction Of Downed Cattle
Into The Food Supply |
|
|
|
|
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C 6693 |
|
T. L. Dale |
|
Vol #: |
|
284 |
|
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C 6694 |
|
no signature |
|
Vol #: |
|
284 |
|
|
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C 6695 |
|
Angela Magnano |
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Vol #: |
|
284 |
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C 6696 |
|
Jechonia Spruill |
|
Vol #: |
|
284 |
|
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|
|
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|
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C 6697 |
|
P. A. Damitz |
|
Vol #: |
|
284 |
|
|
|
C 6698 |
|
Darcy Van Steelant |
|
Vol #: |
|
284 |
|
|
|
C 6699 |
|
Lynda Ream |
|
Vol #: |
|
284 |
|
|
|
C 6700 |
|
Steven Krown |
|
Vol #: |
|
284 |
|
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C 6701 |
|
Trish Lea |
|
Vol #: |
|
284 |
|
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C 6702 |
|
Shirley R. Page |
|
Vol #: |
|
284 |
|
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C 6703 |
|
Rebecca J. Butler |
|
Vol #: |
|
284 |
|
|
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C 6704 |
|
Carole Gillin |
|
Vol #: |
|
284 |
|
|
|
C 6705 |
|
Grace Learn |
|
Vol #: |
|
284 |
|
|
|
C 6706 |
|
Lisa Clark Kahn |
|
Vol #: |
|
284 |
|
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C 6707 |
|
Concetta |
|
Vol #: |
|
284 |
|
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C 6708 |
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Deborah & Arnold Katz
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|
Vol #: |
|
284 |
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C 6709 |
|
Teresa Tyler |
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Vol #: |
|
284 |
|
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C 6710 |
|
Eugene Jung |
|
Vol #: |
|
284 |
|
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C 6711 |
|
Karen Heinlein |
|
Vol #: |
|
284 |
|
|
|
2000N-1484 |
|
Safety Reporting Requirements
Human Drug/Biological Products |
|
|
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NEC 1
|
|
FDA |
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Vol #: |
|
3 |
|
|
|
2001D-0281 |
|
Proposed Globally Harmonized
Alternative for PMA Procedures |
|
|
|
|
|
GDL 2
|
|
Guidance |
|
Vol #: |
|
1 |
|
|
|
NAD 2
|
|
FDA |
|
Vol #: |
|
1 |
|
|
|
2002D-0526
|
|
Guidance
for drug Chemistry, Manufacturing, Control Info. |
|
|
|
|
|
C 8 |
|
Amersham Health |
|
Vol #: |
|
1 |
|
|
|
C 9 |
|
International Pharmaceutical
Excipients Council of the Americas (IPEC-Americas) |
|
Vol #: |
|
1 |
|
|
|
C 10 |
|
AstraZeneca Pharmaceuticals,
LP |
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Vol #: |
|
1 |
|
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C 11 |
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Novartis Pharmaceuticals, Corporation
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|
Vol #: |
|
1 |
Attachments |
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C 12 |
|
GlaxoSmithKline |
|
Vol #: |
|
1 |
|
|
|
C 13 |
|
Johnson & Johnson Pharmaceutical
research & Development, LLC |
|
Vol #: |
|
1 |
|
|
|
2002N-0277 |
|
Bioterrorism; Establishment
& Maintenance of Records |
|
|
|
|
|
C 34 |
|
Restaurant Depot Enterprises,
Inc. |
|
Vol #: |
|
8 |
|
|
|
C 35 |
|
Jetro Cash & Carry Enterprises,
Inc. |
|
Vol #: |
|
8 |
|
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|
2002N-0417 |
|
Applications for FDA Approval
to Market a New Drug |
|
|
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BKG 2 |
|
References 1 - 15 |
|
Vol #: |
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5 |
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NFR 1
|
|
FDA |
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Vol #: |
|
5 |
|
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2003D-0061
|
|
Comparability
Protocols Chemistry Manufacturing and controls |
|
|
C 9 |
|
Johnson & Johnson Pharmaceutical
Research & Development, LLC |
|
Vol #: |
|
1 |
|
|
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C 10 |
|
Number not used |
|
Vol #: |
|
1 |
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|
2003D-0236 |
|
Draft "Guidance for Industry:
Revised Recommendations for Donor and Product Management Based on
Screening Tests for Syphilis;" Availability |
|
|
|
GDL 1
|
|
Guidance |
|
Vol #: |
|
1 |
|
|
|
NAD 1
|
|
FDA |
|
Vol #: |
|
1 |
|
|
|
2003N-0066 |
|
Inspection by Accredited Persons
Under MDUFMA |
|
|
|
|
|
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NAL 1
|
|
FDA |
|
Vol #: |
|
1 |
|
|
|
2003N-0075 |
|
Administrative Detention and
Banned Med.Devices;Agency Infor |
|
|
|
|
|
N 2 |
|
FDA |
|
Vol #: |
|
1 |
|
|
|
2003N-0085 |
|
Environmental Impact Considerations;Agency
Information Colle |
|
|
|
|
|
N 2 |
|
FDA |
|
Vol #: |
|
1 |
|
|
|
2003N-0161 |
|
Medical Devices;Reprocessed
Single-Use Devices;Termination |
|
|
|
|
|
N 2 |
|
FDA |
|
Vol #: |
|
1 |
|
|
|
2003N-0234 |
|
Canned Asparagus Deviating
From Identity Standard; Temporary Permit for Market Testing
|
|
|
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NTP 1
|
|
FDA |
|
Vol #: |
|
1 |
|
|
|
2003N-0267 |
|
Agency Information Collection
Activities; Proposed Collection; Comment Request; Postmarketing
Studies for Licensed Biological Products; Status Reports |
|
|
|
|
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|
|
N 1 |
|
FDA |
|
Vol #: |
|
1 |
|
|
|
2003N-0281 |
|
SARS Diagnostics: Scientific
and Regulatory Challenges Public Workshop |
|
|
|
|
|
NM 1
|
|
FDA |
|
Vol #: |
|
1 |
|
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