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| Dockets Entered
On January 9, 2008
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1978N-0038
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| Sunscreen Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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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-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007D-0419
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| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
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| 2007D-0492
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| Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
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| 2007N-0471
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| Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0283
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| Take actions with respect to NDAs & ANDAs seeking approval of modified release oral dosage form drug products containing opioid active ingredients
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| 2007P-0354
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| Refrain from approving Any Application for a Generic Thalidomide Product
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| 2008P-0012
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| Require that all television advertisements for prescription drugs and over the counter drugs include a toll-free number and a website address for the public to report side effects to the agency
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| 2008P-0015
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| Have Angel Men Eau du Toilette by Thierry Mugler imported and distributed into the United States by Clarins USA Declared Misbranded and Mislabeled
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| 1976N-0052N
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| OTC Nasal Decongestants
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| ACK 13
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| FDA/DDM to NcNeil Consumer Healthcare
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| Vol #:
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| 118
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| CP 21
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| NcNeil Consumer Healthcare
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| Vol #:
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| 118
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| 1978N-0038
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| Sunscreen Drug Products
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| C 727
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| Duke Surgery-Duke University Medical Center
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| Vol #:
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| 182
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| C 728
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| Duke Surgery-Duke University Medical Center
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| Vol #:
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| 182
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 21307
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21308
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21309
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21310
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21311
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| Isaac Marcum
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| Vol #:
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| 183
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| LET 21312
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| Enzymatic Therapy
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| Vol #:
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| 183
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| LET 21313
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| Law Offices of Robert E. Armstrong
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| Vol #:
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| 183
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| LET 21314
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| Russell Y. Minasm, PC Attorney At Law
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| Vol #:
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| 183
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| LET 21315
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| Sound Formulas, LLC
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| Vol #:
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| 183
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| LET 21316
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| Natural Organics, Inc.
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| Vol #:
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| 183
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| LET 21317
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| Natural Organics, Inc.
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| Vol #:
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| 183
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| C 119
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| Exotic Pet & Bird Clinic
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| Vol #:
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| 15
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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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| LET 3
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| FDA/ORA to Andrew K. Krulwich, Benjamin B. Reed and Sarah E. Botha
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| Vol #:
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| 198
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| ELET 1
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| Office of Food Additive Safety, Division of Biotechnology & GRAS Notice Review
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| Vol #:
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| 1
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| C 4277
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| C. Knutson
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| Vol #:
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| 40
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| C 4278
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| J. Goodner
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| Vol #:
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| 40
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| C 4279
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| S. Perriman
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| Vol #:
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| 40
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| C 4280
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| P. Martin
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| Vol #:
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| 40
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 527
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| D. Forbes
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| Vol #:
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| 14
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| 2007D-0419
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| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
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| C 3
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| 2007D-0492
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| Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
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| EC 2
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| feltrex
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| Vol #:
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| 1
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| EC 3
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| mother
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| Vol #:
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| 1
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| EC 4
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| Mr. Brian Flores
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| Vol #:
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| 1
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| EC 5
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| Ms. J Montour
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| Vol #:
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| 1
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| 2007N-0471
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| Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
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| EC 27
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| Fundacion C5 Incompleta AC
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| Vol #:
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| 1
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| EC 28
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| Stepnow Myxico
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| Vol #:
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| 1
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| EC 29
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| Asociaciyn Civil Util y Victorioso
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| Vol #:
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| 1
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| C 368
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| D. Pearson
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| Vol #:
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| 102
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| 2007P-0283
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| Take actions with respect to NDAs & ANDAs seeking approval of modified release oral dosage form drug products containing opioid active ingredients
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| LET 1
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| FDA/CDER to Purdue Pharma, L. P.
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| Vol #:
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| 1
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| C 5
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| Physicians for Social Responsibility
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| Vol #:
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| 1
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| 2007P-0354
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| Refrain from approving Any Application for a Generic Thalidomide Product
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| C 1
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| National Birth Defects Prevention Network
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| Vol #:
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| 1
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| 2008P-0012
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| Require that all television advertisements for prescription drugs and over the counter drugs include a toll-free number and a website address for the public to report side effects to the agency
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| ACK 1
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| FDA/DDM to Consumers Union
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| Vol #:
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| 1
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| CP 1
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| Consumers Union
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| Vol #:
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| 1
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| 2008P-0015
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| Have Angel Men Eau du Toilette by Thierry Mugler imported and distributed into the United States by Clarins USA Declared Misbranded and Mislabeled
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| ACK 1
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| FDA/DDM to National Toxic Encephalopathy Foundation
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| Vol #:
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| 1
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| CP 1
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| National Toxic Encephalopathy Foundation
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| Vol #:
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| 1
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