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| Dockets Management
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| Dockets Entered On June 1, /2006
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| Docket #
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| Title
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| 1984D-0115
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| GUIDELINE FOR SUBMISSION OF STABILITY STUDIES OF HUMAN DR
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| 1985D-0243
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| GUIDELINE FORMAT/CONTENT OF CHEMISTRY MFG/CONTROLS SEC
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| 1993D-0139
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| Stability Testing of Biotechnological/Biological Products
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| 1996D-0010
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| International Conference on Harmonisation;Draft Guideline
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| 1996D-0028
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| Stability Testing for New Dosage Forms, (ICH)
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| 1997D-0448
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| Test Procedures & Acceptance Criteria for New Drug Subs.
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998D-0362
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| Stability Testing of Drug Substances and Drug Products
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| 1998D-0374
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| International Conference on Harmonisation; Draft Guidance
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| 1998D-0994
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| Draft Guidance for Industry on BACPAC I
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| 2000D-0186
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| M4 Common Technical Document;InterNatl Confern on Harmonisat
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| 2000D-1418
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| Q7A ICH Good Manufacturing Practice Guide for Active Pharmac
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| 2001D-0361
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| Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil
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| 2002D-0231
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| Stability Data Pack for Registration Climatic Zones lll & IV
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| 2002D-0237
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| QIE Evaluation of Stability Data
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| 2003D-0061
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| Comparability Protocols Chemistry Manufacturing and controls
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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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-0083
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| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
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| 2006D-0088
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| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
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| 2006D-0198
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| Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptides
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 1984D-0115
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| GUIDELINE FOR SUBMISSION OF STABILITY STUDIES OF HUMAN DR
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| NWL 1
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| FDA
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| Vol #:
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| 2
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| 1985D-0243
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| GUIDELINE FORMAT/CONTENT OF CHEMISTRY MFG/CONTROLS SEC
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993D-0139
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| Stability Testing of Biotechnological/Biological Products
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| NWL 1
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| FDA
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| Vol #:
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| 2
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| 1996D-0010
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| International Conference on Harmonisation;Draft Guideline
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1996D-0028
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| Stability Testing for New Dosage Forms, (ICH)
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1997D-0448
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| Test Procedures & Acceptance Criteria for New Drug Subs.
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17738
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| Phoenix Biologics, Inc.
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| Vol #:
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| 164
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| LET 17739
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17740
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17741
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17742
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17743
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17744
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17745
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17746
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17747
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17748
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17749
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17750
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17751
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17752
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17753
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17754
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17755
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17756
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17757
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17758
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17759
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17760
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| NBTY Inc.
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| Vol #:
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| 164
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| LET 17761
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| Mom Enterprises, Inc.
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| Vol #:
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| 164
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| LET 17762
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 164
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| LET 17763
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 164
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| LET 17764
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 164
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| 1998D-0362
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| Stability Testing of Drug Substances and Drug Products
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| NWL 1
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| FDA
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| Vol #:
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| 5
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| 1998D-0374
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| International Conference on Harmonisation; Draft Guidance
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1998D-0994
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| Draft Guidance for Industry on BACPAC I
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| NWL 1
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| FDA
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| Vol #:
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| 2
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| 2000D-0186
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| M4 Common Technical Document;InterNatl Confern on Harmonisat
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| NWL 1
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| FDA
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| Vol #:
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| 3
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| 2000D-1418
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| Q7A ICH Good Manufacturing Practice Guide for Active Pharmac
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| NWL 1
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| FDA
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| Vol #:
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| 2
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| 2001D-0361
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| Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2002D-0231
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| Stability Data Pack for Registration Climatic Zones lll & IV
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2002D-0237
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| QIE Evaluation of Stability Data
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2003D-0061
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| Comparability Protocols Chemistry Manufacturing and controls
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| NWL 1
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| FDA
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| Vol #:
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| 2
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| NWL 1
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| FDA
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| Vol #:
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| 3
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| LET 4
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| Valeant Pharmaceuticals International
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| Vol #:
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| 3
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| LET 11
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| Tibotec, Inc.
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| Vol #:
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| 2
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| SUP 12
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| Department of the Planet Earth
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| Vol #:
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| 5
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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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