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DOCKETS
ENTERED on May 8, 2003
Docket Number - Title
76N-0377
Certain Drugs Containing Fluoxymesterone & Ethinyl Estrad
94F-0405
Safe use of aspartame as general purpose sweetener
95N-0304
Ephedrine Alkaloids: Reports of Adverse Events; Availability
95S-0158
Community Disclosure of Institutional Review Boards
96N-0417
CGMP in Mfg. Packing or Holding Dietary Supplements
98P-1041
Withdrawn from sale of Tylosterone Tablets
99D-1458
Enforcement Policy for FDA Personnel/Electronic Records& Sig
00N-1484
Safety Reporting Requirements Human Drug/Biological Products
02N-0204
Bar Code Label Requirements for human drug products
02N-0475
Financial Relationships & Interest in Research Involving Hum
02N-0528
Risk Management Workshop, April 9-11, 2003 [PDUFA III]
02P-0435
Effective Approval of Alphanate Antihemophilic Factor
02P-0447
Immediately revoke its acceptance for NDA 21-435 for amlodin
03D-0025
Mammography Quality Standards Act Final Regs.Modifications
03D-0163
Blood Product Safety in Cases of Suspected SARS,Severe Acute
03N-0059
Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
76N-0377 Certain Drugs Containing Fluoxymesterone
& Ethinyl Estrad
HER 2 Solvay Pharmaceuticals, Inc. (Solvay) Vol#: 1
94F-0405 Safe use of aspartame as general purpose
sweetener
EMC 226 Richard T. Murray Vol#: 5
EMC 227 Richard T. Murray Vol#: 5
EMC 228 Diane Baxter Vol#: 5
EMC 229 Jennifer R. Towell Vol#: 5
EMC 230 Betty Martini Vol#: 5
EMC 231 Betty Martini Vol#: 5
EMC 232 Miklos Brauner Vol#: 5
EMC 233 Linda Pugh Vol#: 5
EMC 234 Deanna Vol#: 5
EMC 235 Betty Martini Vol#: 5
EMC 236 Phyllis Weidmann Vol#: 5
EMC 237 Ron Klinger Vol#: 5
EMC 238 Mary Lou Vol#: 5
EMC 239 Betty Martini Vol#: 5
EMC 240 Charmelle2 Vol#: 5
EMC 241 Charmelle2 Vol#: 5
EMC 242 Richard T. Murray Vol#: 5
EMC 243 John Craven Vol#: 5
EMC 244 Kathleen McAuley Vol#: 5
EMC 245 Carla Vol#: 5
EMC 246 Bryant Vol#: 5
EMC 247 Betty Martini Vol#: 5
EMC 248 D. Kern Vol#: 5
EMC 249 D. C. Kern Vol#: 5
EMC 250 Brady McElligott Vol#: 5
EMC 251 Betty Martini Vol#: 5
EMC 252 Betty Martini Vol#: 5
EMC 253 Scott Dykstra Vol#: 5
EMC 254 Betty Martini Vol#: 5
EMC 255 Carmela Quail Vol#: 5
EMC 256 Patrice Vol#: 5
EMC 257 Judith Alta Kidder Vol#: 5
EMC 258 Patrice Vol#: 5
EMC 259 Monell Chemical Senses Center Vol#: 5
EMC 260 Nesie M. Nichols Vol#: 5
95N-0304 Ephedrine Alkaloids: Reports of Adverse
Events; Availability
95N-0309 CGMPs for the Production of Infant Formula
EC 1 Ms. Sheryl Weersing Vol#: 7
EC 2 Mrs. Andrea Mass Vol#: 7
95S-0158 Community Disclosure of Institutional Review
Boards
RPT 9 University of California at Los Angles Vol#: 5
96N-0417 CGMP in Mfg. Packing or Holding Dietary
Supplements
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 6476 Michael & Mary Rose Strasser Vol#: 276
C 6477 Ruth Christianson Vol#: 276
C 6478 E. B. Wolk Vol#: 276
C 6479 Pat Catlin Vol#: 276
C 6480 Ronnie Siegel Vol#: 276
C 6481 Miss Joan E. Bridges Vol#: 276
C 6482 Mr. & Mrs. Knettel Vol#: 276
C 6483 Roberta & Richard R. Getz Vol#: 276
C 6484 Ms. Yvonne Dutcher Vol#: 276
C 6485 Dolores A. Watson Vol#: 276
EMC 3201 Kelly Hughart Vol#: 265
98P-1041 Withdrawn from sale of Tylosterone Tablets
HER 1 Solvay Pharmaceuticals, Inc. (Solvay) Vol#: 1
99D-1458 Enforcement Policy for FDA
Personnel/Electronic Records& Sig
C 21 National Grain & Feed Assn Vol#: 1
00D-1538 Electronic Records; Electronic Signatures, Validation
C 51 Medrad Vol#: 9
C 52 National Grain & Feed Assn Vol#: 9
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec
C 44 Medrad Vol#: 9
C 45 National Grain & Feed Assn Vol#: 9
00D-1542 Electronic Signatures: Time Stamps
C 29 Medrad Vol#: 7
C 30 National Grain & Feed Assn Vol#: 7
00D-1543 Electronic Signatures: Glossary of Terms
C 39 Medrad Vol#: 7
C 40 National Grain & Feed Assn Vol#: 7
00N-1396 Bioengineered Foods Consumed By Humans or Animals
C 9541 Aloria & Doug Gurganus Vol#: 415
C 9542 Elenara Joubert Vol#: 415
C 9543 Lauren E. Richter Vol#: 415
C 9544 Christine Donalies Vol#: 415
C 9545 Carena Curash Vol#: 415
C 9546 T. Jeffrey & B. A. Mangin Vol#: 415
C 9547 T. Jeffrey & B. A. Mangin Vol#: 415
C 9548 Jacob Bricca Vol#: 415
C 9549 Vivian Bryson Vol#: 415
C 9550 Phyllis Johnsen Vol#: 415
C 9551 Anne Evanoff Vol#: 415
C 9552 Jeremy Schwartz Vol#: 415
C 9553 Alicia Dahlen Vol#: 415
00N-1484 Safety Reporting Requirements Human
Drug/Biological Products
02D-0385 Approval of Labeling for Foods Treated by Irradiation
EC 15 Mrs. Michelle Pinkowski Vol#: 1
02N-0204 Bar Code Label Requirements for human drug
products
EC 43 Ohio Department of Mental Health Vol#: 13
EC 44 Mr. Richard VanBuren Vol#: 13
EC 45 Middlesex County Div. of Solid Waste Mgm Vol#: 13
EC 46 Legacy Health System Vol#: 13
EC 47 The Aroostook Medical Center Vol#: 13
EC 48 Caldwell Memorial Hospital Vol#: 13
EC 49 Miss Dawn Lockwood Vol#: 13
02N-0475 Financial Relationships & Interest in
Research Involving Hum
EC 4 University of Pittsburgh Vol#: 1
02N-0528 Risk Management Workshop, April 9-11, 2003
[PDUFA III]
EC 8 Orphan Medical Inc. Vol#: 3
02P-0435 Effective Approval of Alphanate
Antihemophilic Factor
RC 2 Aventis Behring, LLC Vol#: 1
02P-0447 Immediately revoke its acceptance for NDA
21-435 for amlodin
C 2 Frommer Lawrence & Haug, LLP Vol#: 1
03D-0025 Mammography Quality Standards Act Final
Regs.Modifications
C 1 American College of Radiology Vol#: 1
03D-0163 Blood Product Safety in Cases of Suspected
SARS,Severe Acute
EC 3 Mississippi Valley Regional Blood Center Vol#: 1
03N-0059 Pharmaceutical cGMPs for 21st Century: A
Risk-Based Approach
EC 28 Ministry of Health Vol#: 1
EC 29 Mr. ANIL KUKREJA Vol#: 1
03N-0068 Beverages: Bottled Water
EC 9 Mr. Brent Balzarini Vol#: 1
03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition
EC 50 Mrs. Elizabeth Cymerman Vol#: 1
03N-0084 Electronic Records;Electronic Signatures;Agency Information
EC 4 Mr. Denny Walthers Vol#: 1
03N-0142 Submitting & Reviewing Complete Responses for Clinical Holds
EC 2 Ms. pam stevens Vol#: 1