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| Dockets Entered
On March 14, 2006
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002D-0260
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| Prescription drug Samples to Free Clinics
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005D-0434
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| Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
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| 2005D-0438
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| Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| 2005N-0427
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order
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| 2005N-0447
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| Possible Changes to Regulatory Jurisdiction of Certain Food Products Containing Meat and Poultry. Notice of Public Meeting
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| 2005N-0510
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| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
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| 2005P-0182
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| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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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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| 2005P-0420
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| Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
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| 2005P-0440
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| To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2005P-0460
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| Determination of Ramipril Tablets, 1.25 mg, 2.5 mg, 5 mg and 10 mg
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| 2005P-0472
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| ANDA for Ramipril Instant Release Oral Tablets
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| 2006E-0006
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
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| 2006E-0043
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| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990
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| 2006P-0072
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| ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
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| 2006P-0084
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| ANDA Suitability for 1.25 mg, 2.50 mg, 5 mg, and 10 mg Ramipril Tablets
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 315
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| The Procter & Gamble Company
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| Vol #:
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| 251
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| RPT 316
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| Loders Croklaan B.V.
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| Vol #:
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| 253
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| C 9
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| Juice Products Association (JPA)
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| Vol #:
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| 1
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18255
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| K. Jackson
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| Vol #:
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| 516
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| C 78
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| Arizona Osteopathic Medical Association (AOMA)
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| Vol #:
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| 5
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| C 79
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| California Orthopaedic Association
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| Vol #:
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| 5
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| C 80
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| Asthma & Allergy Foundation of America (AAFA)
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| Vol #:
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| 5
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| C 81
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| Wyoming Epilepsy Association
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| Vol #:
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| 5
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| C 82
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| Michigan State Medical Society (MSMS)
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| Vol #:
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| 5
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| LET 19
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| HF-40 to Arizona Osteopathic Medical Association (AOMA)
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| Vol #:
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| 5
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| LET 20
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| HF-40 to California Orthopaedic Association
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| Vol #:
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| 5
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| LET 21
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| HF-40 to Asthma & Allergy Foundation of America (AAFA)
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| Vol #:
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| 5
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| LET 22
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| HF-40 to Wyoming Epilepsy Association
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| Vol #:
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| 5
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| LET 23
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| HF-40 Michigan State Medical Society (MSMS)
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| Vol #:
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| 5
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| C 12848
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| K. Jackson
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| Vol #:
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| 806
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| C 51
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| HIV Medicine Association
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| Vol #:
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| 5
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1371
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| V. Henderson
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| Vol #:
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| 259
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| C 1372
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| R. Moravsky
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| Vol #:
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| 259
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| 2002D-0260
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| Prescription drug Samples to Free Clinics
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| C 2
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| C 51
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| Evanston Northwestern Healthcare (ENH)
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| Vol #:
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| 6
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| 2005D-0434
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| Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
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| C 2
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| Cepheid
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| Vol #:
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| 1
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| | | | | | | | |
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| C 3
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| Advanced Medical Medical Technolgy Association (AdvaMed)
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| Vol #:
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| 1
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| 2005D-0438
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| Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
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| EMC 1
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| C 5
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| Office of the Attorney General State of Illinois
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| Vol #:
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| 1
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| C 6
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| Chocolate Manufacturers Association (CMA)
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| Vol #:
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| 1
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| C 7
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| Environmental Health Coalition (EHC)
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| Vol #:
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| 1
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| EMC 2
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| American Academy of Pediatrics
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| Vol #:
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| 1
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| EMC 3
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| Asociacion Nacional de Fabricantes
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| Vol #:
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| 1
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| EMC 1
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| D. Resnik
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| Vol #:
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| 1
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| 2005N-0427
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 2005N-0447
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| Possible Changes to Regulatory Jurisdiction of Certain Food Products Containing Meat and Poultry. Notice of Public Meeting
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| TR 1
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| Transcript of the December 15, 2005 Joint Meeting with FDA and FSIS
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| Vol #:
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| 2
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| 2005N-0510
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| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
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| EMC 8
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| Healthcare Distribution Management Association (HDMA) et al.
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| Vol #:
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| 3
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| EMC 9
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| Alcan Packaging Kreuzlingen, AG
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| Vol #:
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| 3
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| 2005P-0182
|
| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| LET 4
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| HFM-1 to Simpson Woolley McConacnie, LLP
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| Vol #:
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| 2
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| C 3
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| Council for Responsible Nutrition (CRN)
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| Vol #:
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| 1
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| CR 1
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| Council for Responsible Nutrition (CRN)
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| Vol #:
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| 1
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| 2005P-0377
|
| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| C 2
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| The Aluminum Association
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| Vol #:
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| 3
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|
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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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| EC 9463
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| Mrs. susan hickey
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| Vol #:
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| 41
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|
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| EC 9464
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| Mrs. Harriet Price
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| Vol #:
|
| 41
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| EC 9465
|
| Ms. Angela B
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| Vol #:
|
| 41
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