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Dockets Entered On June 5, 2003 TABLE OF CONTENTS (Linked) | ||||||||||||
| Docket # | Title | |||||||||||
| 2002D-0289 | Surgical Sutures | |||||||||||
| 2002D-0515 | Health Claims labeling conventional foods/dietary supplement | |||||||||||
| 2002N-0434 | Withdrawal of Certain Proposed rules & other propose action | |||||||||||
| 2002N-0475 | Financial Relationships & Interest in Research Involving Hum | |||||||||||
| 2002N-0514 | Irradiation in the production,processing & handling of food | |||||||||||
| 2002N-0528 | Risk Management Workshop, April 9-11, 2003 [PDUFA III] | |||||||||||
| 2002N-0532 | Nonclinical Datasets; Notice of Pilot Project | |||||||||||
| 2003D-0181 | Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA; Availability | |||||||||||
| 2003P-0237 | ANDA Suitability Petition for Propranolol HCI Extended-Release Tablets, 60 mg, 80 mg, 120 mg and 160 mg | |||||||||||
| 2003P-0238 | ANDA Suitability Petition for Clarithromycin Extended-Release Tablets | |||||||||||
| CONTENTS | ||||||||||||
| 2002D-0289 | Surgical Sutures | |||||||||||
| GDL 2 | Anthony Watson | Vol #: | 1 | |||||||||
| NAD 2 | FDA | Vol #: | 1 | |||||||||
| 2002D-0325 | Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate | |||||||||||
| EMC 112 | James M. Nordlund | Vol #: | 3 | |||||||||
| EMC 113 | Daniela Barcello | Vol #: | 3 | |||||||||
| 2002D-0468 | Manufacture and Labeling of Raw Meat Foods | |||||||||||
| EMC 14 | Mardi Montgomery | Vol #: | 1 | |||||||||
| EMC 15 | Joyce Miller | Vol #: | 1 | |||||||||
| EMC 16 | Caroline Brown | Vol #: | 1 | |||||||||
| EMC 17 | Rebecca L.G. erna,MS,DM,CCH | Vol #: | 1 | |||||||||
| EMC 18 | Sharon K. Sherwood | Vol #: | 1 | |||||||||
| EMC 19 | Carrie Reid | Vol #: | 1 | |||||||||
| 2002D-0515 | Health Claims labeling conventional foods/dietary supplement | |||||||||||
| EMC 2 | American Heart Assn | Vol #: | 1 | |||||||||
| 2002N-0275 | Bioterrorism Preparedness; Administrative Detention | |||||||||||
| EMC 19 | Ministry of Agriculture of Ecuador | Vol #: | 3 | ||||||
| EMC 20 | Thomas H. Morse PhD | Vol #: | 3 | ||||||
| EMC 21 | United Customhouse Broker, Inc. | Vol #: | 3 | ||||||
| 2002N-0277 | Bioterrorism; Establishment & Maintenance of Records | ||||||||
| EMC 22 | Water Street Seaford | Vol #: | 4 | ||||||
| EMC 23 | Sol Menashe | Vol #: | 4 | ||||||
| EMC 24 | Ross Consulting,LLC | Vol #: | 4 | ||||||
| EMC 25 | Hawaiian Fruit Specialties, LLC | Vol #: | 4 | ||||||
| 2002N-0434 | Withdrawal of Certain Proposed rules & other propose action | ||||||||
| EMC 1 | Teepak, LLC | Vol #: | 1 | ||||||
| 2002N-0475 | Financial Relationships & Interest in Research Involving Hum | ||||||||
| EMC 4 | Tufts University | Vol #: | 1 | ||||||
| EMC 5 | Johns Hopkins Uniersity | Vol #: | 1 | ||||||
| EMC 6 | Applied Research Ethics National Assn (ARENA) | Vol #: | 1 | ||||||
| EMC 7 | University of Kentucky | Vol #: | 1 | ||||||
| EMC 8 | Fred Hutchinson Cancer Research Center | Vol #: | 1 | ||||||
| EMC 9 | University of Rochester et al. | Vol #: | 1 | ||||||
| 2002N-0514 | Irradiation in the production,processing & handling of food | ||||||||
| NAL 1 | FDA | Vol #: | 1 | ||||||
| SS 1 | Supporting Statement | Vol #: | 1 | ||||||
| 2002N-0528 | Risk Management Workshop, April 9-11, 2003 [PDUFA III] | ||||||||
| EMC 22 | Number Not Used | Vol #: | 3 | ||||||
| EMC 23 | National Assn of Chain Drug Stores (NACDS) | Vol #: | 7 | ||||||
| EMC 24 | Goldsmith Pharmacoigilance & Systems | Vol #: | 7 | ||||||
| EMC 25 | Merck & Co., Inc. | Vol #: | 7 | ||||||
| EMC 26 | International Society of Pharmacoepidemiology (ISPE) | Vol #: | 7 | Day 2 Day 3 | |||||
| EMC 27 | Hoffmann-La Roche | Vol #: | 7 | ||||||
| EMC 28 | RCN Associates, Inc. | Vol #: | 7 | ||||||
| EMC 29 | RCN Assciates, Inc. | Vol #: | 7 | ||||||
| EMC 30 | Johnson & Johnson Pharmaceutical research & Development | Vol #: | 7 | ||||||
| EMC 31 | Eli Lilly and Company | Vol #: | 7 | ||||||
| EMC 32 | Ingenix Epidemiology | Vol #: | 7 | ||||||
| EMC 33 | Biotechnology Industry Organization (BIO) | Vol #: | 7 | Part 2 Part 3 | |||||
| EMC 34 | Johnson & Johnson Pharmaceutical Research & Development, LLC | Vol #: | 7 | ||||||
| EMC 35 | International Society for Pharmacoepidemiology (ISPE) | Vol #: | 7 | ||||||
| 2002N-0532 | Nonclinical Datasets; Notice of Pilot Project | ||||||||
| EMC 2 | Sanofi-Synthelabo Research | Vol #: | 1 | ||||||
| 2002P-0317 | Recall Aspartame as a Neurotoxic Drug | ||||||||
| EMC 246 | Betty Martini | Vol #: | 5 | ||||||
| EMC 247 | Betty Martini | Vol #: | 5 | ||||||
| EMC 248 | Rana McCollum | Vol #: | 5 | ||||||
| EMC 249 | Betty Martini | Vol #: | 5 | ||||||
| 2003D-0181 | Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA; Availability | ||||||||
| GDL 1 | Guidance | Vol #: | 1 | ||||||
| NAD 1 | FDA | Vol #: | 1 | ||||||
| 2003P-0237 | ANDA Suitability Petition for Propranolol HCI Extended-Release Tablets, 60 mg, 80 mg, 120 mg and 160 mg | ||||||||
| ACK 1 | HFA-305 to United Research Laboratories, Inc. | Vol #: | 1 | ||||||
| CP 1 | United Research Laboratories, Inc. | Vol #: | 1 | ||||||
| 2003P-0238 | ANDA Suitability Petition for Clarithromycin Extended-Release Tablets | ||||||||
| ACK 1 | HFA-305 to The Weinberg Group Inc | Vol #: | 1 | ||||||
| CP 1 | The Weinberg Group Inc | Vol #: | 1 | Attachment
1 Attachment 2 | |||||
| 2003V-0239 | Laser Light Show | ||||||||
| ACK 1 | HFA-305 to GEKD, Inc. | Vol #: | 1 | ||||||
| VAR 1 | GEKD, Inc. | Vol #: | 1 | ||||||
Page Updated August 11, 2003:rm