Dockets Entered On July 1, 2003

Table of Contents

Docket #

Title

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

Vol #:

9

C 18

Florida Department of Health

Vol #:

9

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

C 125

B. Bryant

Vol #:

17

C 126

Sharon D. Keeler

Vol #:

17

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

C 6693

T. L. Dale

Vol #:

284

C 6694

no signature

Vol #:

284

C 6695

Angela Magnano

Vol #:

284

C 6696

Jechonia Spruill

Vol #:

284

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

C 6701

Trish Lea

Vol #:

284

C 6702

Shirley R. Page

Vol #:

284

C 6703

Rebecca J. Butler

Vol #:

284

C 6704

Carole Gillin

Vol #:

284

C 6705

Grace Learn

Vol #:

284

C 6706

Lisa Clark Kahn

Vol #:

284

C 6707

Concetta

Vol #:

284

C 6708

Deborah & Arnold Katz

Vol #:

284

C 6709

Teresa Tyler

Vol #:

284

C 6710

Eugene Jung

Vol #:

284

C 6711

Karen Heinlein

Vol #:

284

2000N-1484

Safety Reporting Requirements Human Drug/Biological Products

NEC 1

FDA

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

Vol #:

1

C 11

Novartis Pharmaceuticals, Corporation

Vol #:

1

Attachments

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

2002N-0417

Applications for FDA Approval to Market a New Drug

BKG 2

References 1 - 15

Vol #:

5

NFR 1

FDA

Vol #:

5

2003D-0061

Comparability Protocols Chemistry Manufacturing and controls

C 9

Johnson & Johnson Pharmaceutical Research & Development, LLC

Vol #:

1

C 10

Number not used

Vol #:

1

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

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

NTP 1

FDA

Vol #:

1

2003N-0267

Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Studies for Licensed Biological Products; Status Reports

N 1

FDA

Vol #:

1

2003N-0281

SARS Diagnostics: Scientific and Regulatory Challenges Public Workshop

NM 1

FDA

Vol #:

1