| Food and Drug Administration,
Dockets Management Branch, 5630 Fishers
Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870
[E-mail]
DOCKETS ENTERED on November 5, 1999 Table of Contents(Hyper links are part of the Docket title - not all dockets/documents are linked) |
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95S-0117 Human Drugs Patent Term Extension & New Patents * 96P-0215 Withdrawal Norplant's approval for sale in the United States * 97D-0381 Guidance on Archiving Submissions in Electronic Format * 97P-0350 Reclassify Home Uterine Activity Monitors from III to II * 98D-0317 Electronic Submissions of CRF's, CRT's & Data to CBER * 98P-1194 Withdrawal NADA Approval for Posilac - rBGH * 99D-2212 Quality Systems Regulation Information for Various Premarket * 99D-2729 Industry on BA/BE studies orally administered drug products * 99M-4692 PMA PepGen P-15, P990033 * 99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock * |
LST 48 List as of October 8, 1999 Vol#: 3
96N-0417 CGMP in Packing or Holding Dietary Supplements
TR 3 Transcript of October 21, 1999 meeting Vol#: 6
96P-0215 Withdrawal Norplant's approval for sale in the United States
C 218 Sherie Grotzinger Vol#: 6
97D-0381 Guidance on Archiving Submissions in Electronic Format
EMC 1 Genentech, PROsys LLC Vol#: 1
97P-0350 Reclassify Home Uterine Activity Monitors from III to II
C 1 National Women's Health Network Vol#: 5
98D-0317 Electronic Submissions of CRF's, CRT's & Data to CBER
EMC 1 Genentech, PROsys LLC Vol#: 1
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;
C 163 Edelson Center for Environmental & Preve Vol#: 20
C 164 Edelson Center for Environmental & Preve Vol#: 20
C 165 Edelson Center for Environmental & Preve Vol#: 20
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
C 694 Hon Phil Gramm (CI) Vol#: 23
99D-2212 Quality Systems Regulation Information for Various Premarket
C 3 Orthopedic Surgical Manufacturers Associ Vol#: 1
C 4 Medical Device Manufacturers Association Vol#: 1
99D-2729 Industry on BA/BE studies orally administered drug products
C 4 Procter & Gamble Company Vol#: 1
C 5 Bristoly-Myers Squibb Pharmaceutical Mfg Vol#: 1
C 6 DuPont Pharmaceuticals Company Vol#: 1
C 8 Washington Hospital Center Vol#: 1
C 9 Knoll Pharmaceutical Company Vol#: 1
C 10 Generic Pharamceutical Industry Associat Vol#: 1
C 11 International Generic Pharmaceutical All Vol#: 1
C 12 National Pharamceutical Alliance Vol#: 1
99H-4120 Civil Money Penalty;Joseph R Miller III,dba Potomac Liquor
ANS 1 Office of Tobacco Programs Vol#: 1
99H-4469 Civil Money Penalty;Prestige Stations Inc,dba Arco AM/PM
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4470 Civil Money Penalty;Prestige Stations Inc,dba ARCO AM/PM
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4471 Civil Money Penalty;Sheikhan Shahram,dba ARCO AM/PM
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4472 Civil Money Penalty;Moyle Petroleum Co,dba Common Cents #152
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4473 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4474 Civil Money Penalty;Jung Lee,dba E Z Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4475 Civil Money Penalty;Frank Morello Inc,dba Getty Mini Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4476 Civil Money Penalty;Knight's Inc,dba Knight's Super Food Sto
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4477 Civil Money Penalty;Neighborhood Liquor & Variety Inc,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4478 Civil Money Penalty;Scott Petroleum Corp,dba Scott Petroleum
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4479 Civil Money Penalty;Prakesh Patel,dba TJ's Food Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4480 Civil Money Penalty;Corr-Williams Wholesale Co of Meridian,
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4481 Civil Money Penalty;Don L Resweber Inc,dba Tuffy's Diamond
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4482 Civil Money Penalty;Charles L Webb,dba Webb Truck Stop
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4483 Civil Money Penalty;George Pechin,dba Williamsville Country
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99M-4692 PMA PepGen P-15, P990033
99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 3 Athena M Herrmann Vol#: 1
EMC 23 Nancy E Trageser Vol#: 1
EMC 24 Russell Turbill Vol#: 1
EMC 25 Mha Atma S Khalsa Vol#: 1
EMC 26 Stephen Glanville Vol#: 1
EMC 27 Gerard W Houser Vol#: 1
EMC 28 Jessica L Bekman Vol#: 1
EMC 29 Luke D Arno Vol#: 1
EMC 30 David E Standridge Vol#: 1
EMC 31 Barbara R Dreisbach-Towle Vol#: 1
EMC 32 Brent G Harding Vol#: 1
EMC 33 Judith S Parsons Vol#: 1
EMC 34 Maia Rose Vol#: 1
EMC 35 Abhi Sachdev Vol#: 1
EMC 36 John Arns Vol#: 1
EMC 37 Michele L Ballein Vol#: 1
EMC 38 Robert B Jarrett Vol#: 1
EMC 39 Linda L Tinsley Vol#: 1
EMC 40 Chris Anifantakis Vol#: 1
EMC 41 S M Keenum Vol#: 1
EMC 42 Eugenia Anderson-Ellis Vol#: 1
EMC 43 Sharon Lieberman Vol#: 1
EMC 44 Linda J Fels Vol#: 1
EMC 45 Bob Gilstein Vol#: 1
EMC 46 Michael Casaday Vol#: 1
EMC 47 Kathryn Darrow Vol#: 1
EMC 48 Marion Barnes-Schwartz Vol#: 1
EMC 49 Rosa A Barragan Vol#: 1
EMC 50 Susan Myers Vol#: 1
EMC 51 Plant Rights & 6 others Vol#: 1
EMC 52 Kathleen J Wilk Vol#: 1
EMC 53 Gregg Randell Vol#: 1
EMC 54 Lori B Woosley Vol#: 1
EMC 55 Michael T Hoh Vol#: 1
EMC 56 Tan N Trinh Vol#: 1
EMC 57 Gwendolyn R Taylor Vol#: 1
EMC 58 Chris Dixon Vol#: 1
EMC 59 Virginia L Colclough Vol#: 1
EMC 60 David Kostiner Vol#: 1
EMC 61 Joshua D Berkowitz Vol#: 1
EMC 62 Emily A Phillips Vol#: 1
EMC 63 Dan M Cooper Vol#: 1
EMC 64 Maja C Gray Vol#: 1
EMC 65 Meagan R Miller Vol#: 1
EMC 66 Joan E Summers Vol#: 1
EMC 67 Dee Winters Vol#: 1
EMC 68 Carol Bryson Vol#: 1
EMC 69 Nancy B Spears Vol#: 1
EMC 70 Cara L Richards Vol#: 1
EMC 71 Gregg K Witkins Vol#: 1
EMC 72 Heather M Dowding Vol#: 1
EMC 73 Gian Andrea Morresi Vol#: 1
EMC 74 Suzanne Fisher Vol#: 1
EMC 75 Katie E Easley Vol#: 1
EMC 76 Neal H Crandall Vol#: 1
EMC 77 Louise A Curnow Vol#: 1
EMC 78 Marian Rose Butler Vol#: 1
EMC 79 Leslee Lorraine Freeman Vol#: 1
EMC 80 Jessica Williams Vol#: 1
EMC 81 Sylvia Kaye Viars Vol#: 1
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
ANS 5 Honorable Charles E Grassley (CI) Vol#: 163
C 1775 Form letter count 9 Vol#: 167
99P-2630 Establish a Daily Value for "added sugars"
C 78 Form letters count 47 Vol#: 5