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| Dockets Entered
On October 24, 2007
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| Docket #
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| Title
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| 1997E-0013
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| Reteplase; Patent Term Extension Application No. 5,223,256
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| 2003E-0243
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| Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
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| 2003E-0244
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| Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
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| 2003E-0252
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| Patent Extension for A180 (danofloxacin mesylate), 4,861,779
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| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 2005E-0259
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| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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| 2006E-0034
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| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
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| 2006E-0046
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| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
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| 2006E-0240
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| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
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| 2006E-0354
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| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
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| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
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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-0290
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| Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
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| 2007D-0401
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| Guidance for Industry, FDA, and Foreign Governments: FY 2008 Medical Device User Fee Small Business Qualification and Certification
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| 2007N-0186
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| Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007N-0321
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007P-0047
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| Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
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| 2007P-0235
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| Change the labeling requirements for eggs sold in the United States
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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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| 1997E-0013
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| Reteplase; Patent Term Extension Application No. 5,223,256
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0243
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| Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0244
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| Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0252
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| Patent Extension for A180 (danofloxacin mesylate), 4,861,779
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| LET 9
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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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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| 2005E-0259
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| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0034
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| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0046
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| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0240
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| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
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| |
|
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0354
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| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| SS 1
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| Supporting Statement
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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 4244
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| Number not used
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| Vol #:
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| 40
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| C 4245
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| Number not used
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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 435
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| D. Polastry
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| Vol #:
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| 7
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| C 436
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| D Robique
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| Vol #:
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| 7
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| C 437
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| R Robinson
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| Vol #:
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| 7
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| C 438
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| Unknown
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| Vol #:
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| 7
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| C 439
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| R Law
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| Vol #:
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| 7
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| C 440
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| Unknown
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| Vol #:
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| 7
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| C 441
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| M Warner
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| Vol #:
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| 7
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| C 442
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| R Collson
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| Vol #:
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| 7
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| C 443
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| J Shaffer
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| Vol #:
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| 7
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| C 444
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| J Katz
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| Vol #:
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| 7
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| C 445
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| Y Kita
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| Vol #:
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| 7
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| C 446
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| K Manuell
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| Vol #:
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| 7
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| C 447
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| D El Nahas
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| Vol #:
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| 7
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| C 448
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| M Schroeder
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| Vol #:
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| 7
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| C 449
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| M Kertess
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| Vol #:
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| 7
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| C 450
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| L Harris
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| Vol #:
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| 7
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| C 451
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| C Neyman
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| Vol #:
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| 7
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| C 452
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| H Blu
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| Vol #:
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| 7
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| C 453
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| C Kelemen
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| Vol #:
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| 7
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| C 454
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| A Adolph
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| Vol #:
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| 7
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| C 455
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| R Goodin
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| Vol #:
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| 7
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| C 456
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| A Byrne
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| Vol #:
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| 7
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| C 457
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| J Kaidjak
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| Vol #:
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| 7
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| C 458
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| T Angell
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| Vol #:
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| 7
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| C 459
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| L Horrigan
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| Vol #:
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| 7
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| C 460
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| A Parrish
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| Vol #:
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| 7
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| 2007D-0290
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| Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
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| C 1
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| Hyman, Phelps & McNamara (HPM)
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| Vol #:
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| 1
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| 2007D-0401
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| Guidance for Industry, FDA, and Foreign Governments: FY 2008 Medical Device User Fee Small Business Qualification and Certification
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0186
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| Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
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| EREG 3
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| A. Shao
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| Vol #:
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| 1
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| C 3
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| The American Association for Respiratory Care (AARC)
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| Vol #:
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| 1
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| 2007N-0321
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Experimental Evaluation
of the Impact of Distraction on Consumer Understanding of Risk and
Benefit Information in Direct
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| C 5
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| The American Academy of Orthopaedic
Surgeons (AAOS/Academy)
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| Vol #:
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| 1
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY
OF CERTAIN DRUGS; Public Meeting
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| EAPE 184
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| Mann Healthcare Ltd
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| Vol #:
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| 1
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| EAPE 185
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| Avalere Health LLC
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| Vol #:
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| 1
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| EC 25
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| Mr. Monte Thompson
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| Vol #:
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| 1
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| 2007P-0047
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| Amend the Dosage of Oral Phenylephrine
Listed in the Final Monogrph on Oral Decongestants
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0235
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| Change the labeling requirements
for eggs sold in the United States
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| C 209
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| E Ody
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| Vol #:
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| 2
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| C 210
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| Unknown
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| Vol #:
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| 2
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| C 211
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| R Robinson
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| Vol #:
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| 2
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| C 212
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| unknown
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| Vol #:
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| 2
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| C 213
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| R Law
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| Vol #:
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| 2
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| C 214
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| M Warner
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| Vol #:
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| 2
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| C 215
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| R Collson
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| Vol #:
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| 2
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| C 216
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| J Shaffer
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| Vol #:
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| 2
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| C 217
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| J Katz
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| Vol #:
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| 2
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| C 218
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| Y Kita
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| Vol #:
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| 2
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| C 219
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| K Manuell
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| Vol #:
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| 2
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| C 220
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| D El Nahas
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| Vol #:
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| 2
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| C 221
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| M Schroeder
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| Vol #:
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| 2
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| C 222
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| M Kertess
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| Vol #:
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| 2
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| C 223
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| L Harris
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| Vol #:
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| 2
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| C 224
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| C Neyman
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| Vol #:
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| 2
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| C 225
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| H Blu
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| Vol #:
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| 2
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| C 226
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| C Kelemen
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| Vol #:
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| 2
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| C 227
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| A Adolph
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| Vol #:
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| 2
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| C 228
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| R Goodin
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| Vol #:
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| 2
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| C 229
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| A Byrne
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| Vol #:
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| 2
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| C 230
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| J Kaidjak
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| Vol #:
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| 2
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| C 231
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| T Angell
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| Vol #:
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| 2
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| C 232
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| L Horrigan
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| Vol #:
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| 2
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| C 233
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| A Parrish
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| Vol #:
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| 2
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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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| |
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| EC 17
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| Mrs. Marina Yuan
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| Vol #:
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| 1
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