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| Dockets Entered
On September 1, 2006
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004N-0234
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| Annual Guidance Agenda
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006N-0203
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| Agency Information Collection Activities; Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0328
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions 21 CFR Part 571 ; Extension
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0298
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| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| 2006P-0300
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| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
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| 2006P-0302
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| Permit the filing of an ANDA Suitability for Sodium Chloride Injection
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC 1
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| Mr. Michael Edmond
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| Vol #:
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| 4
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| EC 2
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| Ms. Toni Jeter
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| Vol #:
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| 4
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 18082
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18083
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18084
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18085
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18086
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18087
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18088
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18089
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18090
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18091
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18092
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18093
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| PuraPharm International (H.K.) Ltd
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| Vol #:
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| 167
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| LET 18094
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18095
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18096
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18097
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18098
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| Arkopharma LLC
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| Vol #:
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| 167
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| LET 18099
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| Arkopharma LLC
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| Vol #:
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| 167
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 690
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 691
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 692
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 693
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| Mission Possible International
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| Vol #:
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| 10
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 21
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| Mr. Dave Lowe
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| Vol #:
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| 8
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EMC 1568
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| S. Petrosky
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| Vol #:
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| 22
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| 2004N-0234
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| Annual Guidance Agenda
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| EMC 793
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| L. Pedota
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| Vol #:
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| 9
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| LET 2
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| TMJ Implants, Inc. and Robert W. Christensen and Maureen K Mooney
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| Vol #:
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| 6
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| EMC 1
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| J. Benner
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| Vol #:
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| 4
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| EMC 8
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| Form Letter
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| Vol #:
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| 5
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| EMC 32
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| J. Waugaman
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| Vol #:
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| 1
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| EMC 33
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| J. Imbeau D.M.D., FACNEM
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| Vol #:
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| 1
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| EMC 34
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| S. Miller
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| Vol #:
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| 1
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| EMC 35
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| D. Chapman, DDS
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| Vol #:
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| 1
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| EMC 36
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| B. Redstone
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| Vol #:
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| 1
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| EMC 37
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| S. Davidson
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| Vol #:
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| 1
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| EC 577
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| Mrs. L. Merrell
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| Vol #:
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| 5
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| EC 578
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| Mr. Reggie McLean
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| Vol #:
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| 5
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| EC 579
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| Mr. Jeff Smallwood
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| Vol #:
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| 5
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| EMC 37
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| S. Gresham
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| Vol #:
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| 2
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| EMC 38
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| J. Anderson
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| Vol #:
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| 2
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| 2006P-0298
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| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0300
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| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0302
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| Permit the filing of an ANDA Suitability for Sodium Chloride Injection
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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