Dockets Entered On 05/20/2003

      Docket # Title

2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

2001P-0120 Ban Unsafe IV Catheters and other Devices

2001P-0323 Not rely on non-public filings to approve an innovator NDA;

2001P-0574 Referencing discontinued labeling for Octreotide acetate inj

2002D-0515 Health Claims labeling conventional foods/dietary supplement

2002D-0526 Guidance for drug Chemistry, Manufacturing, Control Info.

2002N-0204 Bar Code Label Requirements for human drug products

2002N-0475 Financial Relationships & Interest in Research Involving Hum

2002N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

2002N-0534 Medical Device User Fee and Modernization Act of 2002

2002P-0029 Mylan estradiol transdermal system as generic substitute

2002P-0406 ANDA Suitability for Amoxicillin & Clavulanate Potassium

2002P-0483 Actions re: exceptive drug products, ex release guaifenesin

2002P-0493 Anti-heart burn drug Omeprazole magnesium (brand Prilosec1)

2002P-0499 ANDA Suitability for Metformin Hydrochloride Tablets Oral So

2002P-0506 Was Wydase (Hyaluronidase) Inj. Withdrawn-Safety Reasons

2003D-0001 Nonclinical Safety Evaluation of Pediatric Drug Products

2003D-0044 Reporting Results for Studies Evaluating Diagnostic Tests  

      1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements

      NEC 2 FDA Vol #: 7

      1998D-0785 Medical imaging drugs and biologics

      GDL 3 Guidance for Industry Vol #: 5

      GDL 4 Guidance for Industry Vol #: 5

      GDL 5 Guidance for Industry Vol #: 5

      NAD 3 FDA Vol #: 5

      1999N-2637 Public Information Regulations

      NFR 1 FDA Vol #: 1

    2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

      C 244 Montana Naral Vol #: 38

      C 245 Joan P. Milloy Vol #: 38

      C 246 Laurie DeSimone Vol #: 38

      C 247 David C. Reardon, PhD Vol #: 38

      C 248 D. Gene Lakey, Jr. Vol #: 38

      C 249 Suzanne King Vol #: 38

      C 250 Salem Pregnancy Care Center Vol #: 38

      C 251 Suzanne N. Walczak, M-3 Vol #: 38

      C 252 Karen Louise Davis Vol #: 38

      C 253 Paula Westwood Vol #: 38

      C 254 Susan Hendrix Vol #: 38

      C 255 Rosemary & Jim Benefield Vol #: 38

      C 256 Jo An Carter Vol #: 38

      C 257 Joy Greco-Yanez Vol #: 38

      C 258 Rev Mr Thomas E. MacDougall Vol #: 38

      C 259 Montana Naral Vol #: 38

      C 260 Montana Naral Vol #: 38

      C 261 James P. Freund Vol #: 38

      C 262 Kristy Kade Vol #: 38

      C 263 Ann K. Brown Vol #: 38

      C 264 Kathryn Brinner Vol #: 38

      LET 4 Ruth Archambault Vol #: 38

    2001P-0120 Ban Unsafe IV Catheters and other Devices

      C 33 Public Citizen Health Research Group Vol #: 3

    2001P-0323 Not rely on non-public filings to approve an innovator NDA;

      C 5 Biotechnology Industry Organization (BIO) Vol #: 1

    2001P-0574 Referencing discontinued labeling for Octreotide acetate inj

      RC 7 Ben Venue Laboratories, Inc. Vol #: 1

    2002D-0515 Health Claims labeling conventional foods/dietary supplement

      C 3 Grocery Manufacturers of America Vol #: 1

    2002D-0526 Guidance for drug Chemistry, Manufacturing, Control Info.

      C 1 Paul G. King Consulting?FAME Systems Vol #: 1

      2002H-0443 Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

      CS 8 HFA-305 Vol #: 1

      MO 6 GCF-1 Vol #: 1

    2002N-0204 Bar Code Label Requirements for human drug products

      C 39 intelliDOT Vol #: 13

      C 40 Erie Medical Vol #: 13

      2002N-0275 Bioterrorism Preparedness; Administrative Detention

      LST 1 List of questions during May 7, 2003 satellite downlink Vol #: 3

      2002N-0276 Bioterrorism Preparedness;Registration of Food Facilities

      TR 2 Transcript of Proposed Rules on Bioterrorism May 7, 2003 Vol #: 14

      2002N-0277 Bioterrorism; Establishment & Maintenance of Records

      LST 1 List of question during satellite dowlink Vol #: 4

      2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

      C 220 United States Congress Vol #: 14

    2002N-0475 Financial Relationships & Interest in Research Involving Hum

      C 3 National Hemophilia Foundation Vol #: 1

      C 4 Parallax Medical, Inc. Vol #: 1

    2002N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

      C 8 CERTs Program Vol #: 1

    2002N-0534 Medical Device User Fee and Modernization Act of 2002

      C 31 MassMEDIC Vol #: 2

    2002P-0029 Mylan estradiol transdermal system as generic substitute

      M 1 HFD-48 Vol #: 1

    2002P-0406 ANDA Suitability for Amoxicillin & Clavulanate Potassium

      RC 1 The Weinberg Group, Inc. Vol #: 1

    2002P-0483 Actions re: exceptive drug products, ex release guaifenesin

      LET 1 HFD-005 to Kirkpatrick & Lockhart, LLP Vol #: 1

    2002P-0493 Anti-heart burn drug Omeprazole magnesium (brand Prilosec1)

      LET 1 HFD-1 to Zuckerman Spaeder, LLP Vol #: 1

    2002P-0499 ANDA Suitability for Metformin Hydrochloride Tablets Oral So

      PAV 1 HFD-600 to The Weinberg Group, Inc. Vol #: 1

    2002P-0506 Was Wydase (Hyaluronidase) Inj. Withdrawn-Safety Reasons

      LET 1 HFD-005 to Lachman Consultant Services, Inc. Vol #: 1

    2003D-0001 Nonclinical Safety Evaluation of Pediatric Drug Products

      C 9 Covance Laboratories, Ltd. Vol #: 1

    2003D-0044 Reporting Results for Studies Evaluating Diagnostic Tests

      C 2 American Assn for Clinical Chemistry (AACC) Vol #: 1  

      2003D-0061 Comparability Protocols Chemistry Manufacturing and controls

       C 1 Paul G. King Consulting/FAME SYSTEMS Vol #: 1

      EC 4 Grover, Steven Vol #: 1

      2003M-0189 P010055 - ProstaLund? CoreTherm? System Microwave Thermotherapy

      for BPH, Approved 12/23/02

      AAV 1 ProstaLund Operations AB Vol #: 1

      2003M-0190 P980035/S013 - Medtronic AT500 DDDRP Pacing System (Model

      AT501) and Model 9968 Software, Approved 3/27/03

      AAV 1 Medtronic, Inc. Vol #: 1

      2003N-0069 FDA Task Force on Consumer Health Info for Better Nutrition

      EC 55 Pearce, Verrie Vol #: 2

      EC 57 Feola, Natacha Vol #: 2

      2003N-0134 Team Biologics Program Effectiveness; Public Meeting

      APE 40 CBER Vol #: 1

      APE 41 Immune Deficiency Foundation Vol #: 1

      APE 42 CBER Vol #: 1

      2003N-0158 Specification for Annotated Electrocardiographic Waveform

      EC 3 Fager, Gunnar Vol #: 1