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Dockets
Entered On June 2, 2003
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| Docket # | Title | ||||||||
| 1991D-0407 | Resorbable Calcium Salt Bone Void Filler Device | ||||||||
| 1993P-0174 | Amend Regs for Liquid Medicated Animal Feed | ||||||||
| 1995F-0221 | Safe Use of Natamycin In Broiler Chicken Feed | ||||||||
| 1996N-0417 | CGMP in Mfg. Packing or Holding Dietary Supplements | ||||||||
| 1997N-0449 | Revisions to General Safety Requirements for Biological Products | ||||||||
| 2001N-0411 | Calcium Salt Bone Void Filler Device | ||||||||
| 2001P-0075 | Switch Status of Emergency Contraceptives from Rx to OTC | ||||||||
| 2002D-0388 | Establishing Pregnancy Exposure Registries | ||||||||
| 2002F-0327 | ADM Alliance Nutrition, Inc.;Animal Use Feed-Grade Biuret | ||||||||
| 2002N-0077 | Emergency Med. Device Shortage Program Survey;Agency Informa | ||||||||
| 2002N-0204 | Bar Code Label Requirements for human drug products | ||||||||
| 2002N-0452 | Effectiveness of New Drugs When Human Efficacy Studies | ||||||||
| 2002N-0475 | Financial Relationships & Interest in Research Involving Hum | ||||||||
| 2002N-0516 | Request for Samples and Protocols;Agency Information Collect | ||||||||
| 2002N-0528 | Risk Management Workshop, April 9-11, 2003 [PDUFA III] | ||||||||
| 2002P-0479 | Cyproheptadine Hydrochloride Tablets;Assign a (RLD) status | ||||||||
| 2002P-0489 | Request Revision of CVM's Bioequivalence Guidelines | ||||||||
| 2003D-0137 | Surgical Masks - Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and FDA; Availability | ||||||||
| 2003N-0038 | Medical Device User Fee Cover Sheet;Form FDA 3601 | ||||||||
| 2003N-0135 | List of US Dairy Prod. Mfg.w/ Interest in Exporting to Chile | ||||||||
| 2003N-0170 | Report on the Performance
of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies;
AvailabilityACTION: Notice of availability. | ||||||||
| 2003N-0187 | Agency Information Collection Activities: Proposed Collection; Comment Request; | ||||||||
| 2003N-0194 | Agency Information Collection Activities: Proposed Collection: Comment Request; Agreement for Shipment of Devices for Sterilization | ||||||||
| 2003P-0223 | ANADA Suitability for Ivermectin | ||||||||
| 1991D-0407 | Resorbable Calcium Salt Bone Void Filler Device | |||||||||||
| GDL 2 | Guidance for Industry | Vol #: | 1 | |||||||||
| NAD 2 | FDA | Vol #: | 1 | |||||||||
| 1993P-0174 | Amend Regs for Liquid Medicated Animal Feed | |||||||||||
| NPR 1 | FDA | Vol #: | 1 | |||||||||
| 1995F-0221 | Safe Use of Natamycin In Broiler Chicken Feed | |||||||||||
| N 1 | FDA | Vol #: | 9 |
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| 1995N-0304 | Ephedrine Alkaloids: Reports of Adverse Events; Availability | |||||||||||
| C 4029 | Gary Graf, ARNP | Vol #: | 374 | |||||||||
| 1996N-0417 | CGMP in Mfg. Packing or Holding Dietary Supplements | |||||||||||
| C 114 | Rebecca Natural Food | Vol #: | 7 | |||||||||
| 1997N-0449 | Revisions to General Safety Requirements for Biological Products | |||||||||||
| SS 1 | Supporting Statement | Vol #: | 1 | |||||||||
| 2001N-0411 | Calcium Salt Bone Void Filler Device | |||||||||||
| NFR 1 | FDA | Vol #: | 1 | |||||||||
| 2001P-0075 | Switch Status of Emergency Contraceptives from Rx to OTC | |||||||||||
| C 284 | Arlene Henneberry | Vol #: | 38 | |||||||||
| C 285 | Ellen L. Markham | Vol #: | 38 | |||||||||
| C 286 | Maureen Kubasky | Vol #: | 38 | |||||||||
| C 287 | Marie Barth | Vol #: | 38 | |||||||||
| C 288 | University of Minnesota | Vol #: | 38 | |||||||||
| 2002D-0388 | Establishing Pregnancy Exposure Registries | |||||||||||
| C 1 | Hoffman-LaRoche, Inc. | Vol #: | 1 | |||||||||
| 2002F-0327 | ADM Alliance Nutrition, Inc.;Animal Use Feed-Grade Biuret | |||||||||||
| NFR 1 | FDA | Vol #: | 1 | |||||||||
| 2002N-0077 | Emergency Med. Device Shortage Program Survey;Agency Informa | |||||||||||
| NAL 2 | FDA | Vol #: | 1 | |||||||||
| 2002N-0204 | Bar Code Label Requirements for human drug products | |||||||||||
| C 47 | Applied Digital Solutions (ADS) | Vol #: | 13 | |||||||||
| 2002N-0452 | Effectiveness of New Drugs When Human Efficacy Studies | |||||||||||
| NAL 1 | FDA | Vol #: | 1 | |||||||||
| SS 1 | Supporting Statement | Vol #: | 1 | |||||||||
| 2002N-0475 | Financial Relationships & Interest in Research Involving Hum | |||||||||||
| C 17 | University of Minnesota | Vol #: | 1 | |||||||||
| C 18 | Advanced Medical technology Assn | Vol #: | 1 | |||||||||
| C 19 | Purdue University | Vol #: | 1 | |||||||||
| 2002N-0516 | Request for Samples and Protocols;Agency Information Collect | ||||||||
| N 2 | FDA | Vol #: | 1 | ||||||
| 2002N-0528 | Risk Management Workshop, April 9-11, 2003 [PDUFA III] | ||||||||
| C 13 | Ingenix Epidemiology | Vol #: | 3 | ||||||
| 2002P-0479 | Cyproheptadine Hydrochloride Tablets;Assign a (RLD) status | ||||||||
| N 1 | FDA | Vol #: | 1 | ||||||
| 2002P-0489 | Request Revision of CVM's Bioequivalence Guidelines | ||||||||
| LET 1 | HFC-1 to James H. Schafer,DVM | Vol #: | 1 | ||||||
| 2003D-0137 | Surgical Masks - Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and FDA; Availability | ||||||||
| GDL 1 | Guideline | Vol #: | 1 | ||||||
| NAD 1 | FDA | Vol #: | 1 | ||||||
| 2003N-0038 | Medical Device User Fee Cover Sheet;Form FDA 3601 | ||||||||
| N 2 | FDA | Vol #: | 1 | ||||||
| 2003N-0135 | List of US Dairy Prod. Mfg.w/ Interest in Exporting to Chile | ||||||||
| NAL 1 | FDA | Vol #: | 1 | ||||||
| SS 1 | Supporting Statement | Vol #: | 1 | ||||||
| 2003N-0169 | Dental Amalgam; Request for Information | ||||||||
| SUP 3 | Hal A. Higgins, DDS, MS | Vol #: | 1 | ||||||
| 2003N-0170 | Report on the Performance
of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies;
AvailabilityACTION: Notice of availability. | ||||||||
| N 1 | FDA | Vol #: | 1 | ||||||
| 2003N-0187 | Agency Information Collection Activities: Proposed Collection; Comment Request; | ||||||||
| N 1 | FDA | Vol #: | 1 | ||||||
| 2003N-0194 | Agency Information Collection Activities: Proposed Collection: Comment Request; Agreement for Shipment of Devices for Sterilization | ||||||||
| N 1 | FDA | Vol #: | 1 | ||||||
| 2003P-0223 | ANADA Suitability for Ivermectin | ||||||||
| ACK 1 | HFA-305 to Richdel, Inc. | Vol #: | 1 | ||||||
| CP 1 | Richdel, Inc. | Vol #: | 1 | ||||||