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DOCKETS
ENTERED on May 1, 2003
Docket Number - Title
75N-0069
RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS
95N-0304
Ephedrine Alkaloids: Reports of Adverse Events; Availability
96N-0417
CGMP in Mfg. Packing or Holding Dietary Supplements
97S-0162
30-Day Structure Function Claim Notification Letters Dietary
99D-1458
Enforcement Policy for FDA Personnel/Electronic Records& Sig
02D-0337
Liposome Drug Products:Chemistry, Manufacturing, and Control
02N-0204
Bar Code Label Requirements for human drug products
02N-0528
Risk Management Workshop, April 9-11, 2003 [PDUFA III]
02N-0534
Medical Device User Fee and Modernization Act of 2002
02P-0469
ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2%
03D-0163
Blood Product Safety in Cases of Suspected SARS,Severe Acute
03P-0089
Loratadine in 10 Milligrams Orally Disintegrating Tablets
03P-0132
Part 135 FDA regulations standard of identity frozen dessert
03P-0160
FDA to send letter ruling refusing to approve loratadine tab
03P-0183
180 Day Tentative responses under 21CFR5.10/21CFR 10.30
03P-0184
Permit filing of ANDA for nafcillin for injection, USP, phar
C 1 ACNP, American College of Nuclear Physic Vol#: 1
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims
C 2456 Mrs. Yvonne C. Ahern Vol#: 70
C 2457 Dawn Rohn Vol#: 70
C 2458 Nancy L. Weber Vol#: 70
C 2459 Jane Engel Vol#: 70
C 2460 Mrs. Christina Deichler Vol#: 70
C 2461 Ronnie Hostmeyer Vol#: 70
C 2462 Pamela Hosler Vol#: 70
C 4017 State of New Jersey Vol#: 348
C 4018 Presence Marketing/Dynamic Presence,Inc. Vol#: 348
C 4019 Ben R. Munguia Vol#: 348
C 4020 Robert Graham Vol#: 348
RPT 7 Sen Kennedy,Sen Durbin,Rep. Waxman Vol#: 348
95N-0309 CGMPs for the Production of Infant Formula
BKG 2 Background Material Vol#: 7
NEC 2 Vol#: 7
EC 14 Enzyme Technical Association Vol#: 7
96V-0474 Variance Application for High Pressure Mercury Vapor Lamps
VRA 3 HFZ-300 to General Electric Co. Vol#: 1
LET 10157 FoodScience Corporation Vol#: 77
LET 10158 Higher Nature Nutrional Excellence Vol#: 77
LET 10159 Northwest Natural Products Vol#: 77
LET 10160 TMG Industries Vol#: 77
LET 10161 Integrative Therapeutics Inc. Vol#: 77
LET 10162 Integrative Therapeutics Inc. Vol#: 77
LET 10163 Insight Pharmaceuticals Corp. Vol#: 77
LET 10164 Integrative Therapeutics Inc. Vol#: 77
LET 10165 Avon The Company for Women Vol#: 77
LET 10166 Avon The Company for Women Vol#: 77
LET 10167 Avon The Company for Women Vol#: 77
LET 10168 Avon The Cmpany for Women Vol#: 77
LET 10169 Avon The Company for Women Vol#: 77
LET 10170 Avon The Company for Women Vol#: 77
LET 10171 Perrigo Company of South Carolina Vol#: 77
LET 10172 Integrative Therapeutics Inc. Vol#: 77
LET 10173 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10174 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10175 Integrative Therapeutics Inc. Vol#: 77
LET 10176 Integrative Therapeutics Inc. Vol#: 77
LET 10177 Integrative Therapeutics Inc. Vol#: 77
LET 10178 Twin laboratories, Inc. Vol#: 77
LET 10179 Twin Laoratories, Inc. Vol#: 77
LET 10180 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10181 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10182 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10183 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10184 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10185 PhytoPharmica Natural Medicines Vol#: 77
LET 10186 PhytoPharmica Natural Medicines Vol#: 77
LET 10187 Tabak's Health Products Vol#: 77
LET 10188 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10189 Enzymatic Therapy natural Medicines Vol#: 77
LET 10190 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10191 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10192 Enzymatic Therapy Natural Medicines Vol#: 77
97V-0106 Laser Light Show
VRA 3 HFZ-300 to The Omnisphere - The Coca Col Vol#: 1
C 18 National Food Processors Assn (NFPA) Vol#: 1
C 19 Bectin, Dickinson & Company (BD) Vol#: 1
00D-1538 Electronic Records; Electronic Signatures, Validation
C 49 National Food Processors Assn (NFPA) Vol#: 9
C 50 Bectin, Dickinson & Company (BD) Vol#: 9
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec
C 42 National Food Processors Assn (NFPA) Vol#: 9
C 43 Bectin, Dickinson & Company (BD) Vol#: 9
00D-1542 Electronic Signatures: Time Stamps
C 27 National Food Processors Assn (NFPA) Vol#: 7
C 28 Bectin, Dickinson & Company (BD) Vol#: 7
00D-1543 Electronic Signatures: Glossary of Terms
C 37 National Food Processors Assn (NFPA) Vol#: 7
C 38 Bectin, Dickinson & Company (BD) Vol#: 7
00E-1403 Patent Extension Prevnair, No. 5,360,897
N 1 HFD-5 to U.S. Patent & Trademark Office Vol#: 1
00N-1396 Bioengineered Foods Consumed By Humans or Animals
C 9538 Peter Miller Vol#: 408
C 9539 Udom Likhitwonnawut Vol#: 408
C 9540 Leilan Fintus Vol#: 408
01P-0230 Domestic Marketing & Importation of Transgenic Fish
C 1330 Ruth Miale Vol#: 233
02D-0324 Bioengineered Plants for Use in Humans and Animals
C 639 Joon L. Fitzsimmons Vol#: 13
C 640 Marilyn Cox Vol#: 13
C 641 Larrell R. Brown Vol#: 13
C 10 Biologistic Services Vol#: 1
02E-0345 Patent Term Application for Aromanis No. 4,808,616
N 1 HFD-5 to U.S. Patent & Trademark Office Vol#: 1
C 36 Allergy Laboratories, Inc. Vol#: 13
C 37 Michael C. Loftin, P.D. Vol#: 13
EC 41 Kaweah Delta District Hospital Vol#: 13
EC 42 St Joseph's/Candler Health System Vol#: 13
02N-0275 Bioterrorism Preparedness; Administrative Detention
C 22 Alpine Marketing Vol#: 3
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities
EC 270 Mr. Carl Heckel Vol#: 11
02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
C 219 Assn of American Railroads Vol#: 14
C 6 McKesson Corporation Vol#: 2
EC 6 American Society of Health-System Pharma Vol#: 2
02P-0435 Effective Approval of Alphanate Antihemophilic Factor
C 15 Louis M. Aledort, MD Vol#: 1
LET 2 HFD-1 to Allergan, Inc. Vol#: 1
02V-0411 Laser light show
VRA 1 HFZ-300 to Live Bait Vol#: 1
02V-0504 Laser Light Show
VRA 1 HFZ-300 to Swinomish Northern Lights Cas Vol#: 1
03D-0060 Part11, Electronic records, electronic signatures scope
C 26 Karen Raskasky Vol#: 1
C 27 GlaxoSmithKline Vol#: 1
C 28 National Food Processors Assn (NFPA) Vol#: 1
C 29 Bectin, Dickinson & Company (BD) Vol#: 1
EC 18 APV e.V. Vol#: 1
EC 19 H. Lundbeck Vol#: 1
EC 20 Invensys Vol#: 1
EC 21 Number Not Used Vol#: 1
EC 22 Eli Lilly & Co. Vol#: 1
EC 23 Baxter Pharmaceutical Solutions LLC Vol#: 1
EC 24 Pharma Quality Europe Vol#: 1
EC 25 Consultant Vol#: 1
EC 26 National Food Processors Association Vol#: 5
EC 27 America's Blood Centers Vol#: 1
EC 28 Lipid Sciences, Inc. Vol#: 1
EC 29 PharmTech, Inc. Vol#: 1
C 2 San Diego Blood Bank Vol#: 1
EC 1 Community Blood Center Vol#: 1
EC 2 Mississippi Blood Services Vol#: 1
03F-0128 Permitted Use Concentration and to Expand pH Range for acidi
EC 1 Number Not Used Vol#: 2
03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
EC 27 Ms. marti worth Vol#: 1
03N-0065 MDUFMA Small Business Qualification Certification
NAL 1 Vol#: 1
SS 1 Supporting Statement Vol#: 1
03N-0066 Inspection by Accredited Persons Under MDUFMA
N 1 Vol#: 1
03N-0077 Recognition List Number 008
N 1 Vol#: 1
03N-0084 Electronic Records;Electronic Signatures;Agency Information
EC 3 none Vol#: 1
C 2 IDFA, International Dairy Foods Assn. Vol#: 1
ACK 1 HFA-305 Vol#:
ACK 1 HFA-305 Vol#: 1
CP 1 Samson Medical Technologies, L.L.C. Vol#: 1
03V-0095 Laser Light Show
VRA 1 HFZ-300 to FX Unlimited Vol#: 1
03V-0127
VRA 1 HFZ-300 to Entertainment Service dba Ang Vol#: 1
03V-0185
ACK 1 HFA-305 to Creative Consultants Laser Im Vol#: 1
VAR 1 Creative Consultants, LLC Vol#: 1