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Dockets Entered On April 6, 2006
Docket # Title
2004N-0226 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0112 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities
2006D-0128 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions
2006N-0109 General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
2006N-0127 Medical Device Reporting; Premarket Approval of Medical Devices; Quality System Regulation; Obstetrical and Gynecological Devices; Ophthalmic Devices; Technical Amendment
2004N-0226 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
N 5 FDA Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
M 1 GCF-1 to Hon. Daniel J. Davidson, ALJ Vol #: 3
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 5286 S. MacDonald Vol #: 84
C 5287 R. Mallory Vol #: 84
C 5288 C. Hepp Vol #: 84
C 5289 J. DiDonato Vol #: 84
C 5290 A. Silverthorne Vol #: 84
C 5291 L. Rumsey Vol #: 84
C 5292 M. Celentano Vol #: 84
C 5293 Eligible Vol #: 84
C 5294 D. Winn Vol #: 84
C 5295 K. Lindsey Vol #: 84
C 5296 B. Nolls Vol #: 84
C 5297 N. Hopson Vol #: 84
C 5298 L. Robbins Vol #: 84
C 5299 V. Barthel Vol #: 84
C 5300 L. Rumbaugh, MD Vol #: 84
C 5301 P. Zimmerman Vol #: 84
C 5302 M. Sharp Vol #: 84
C 5303 B. Severe Vol #: 84
C 5304 A. Addis Vol #: 84
C 5305 S. Jones Vol #: 84
C 5306 S. French Vol #: 84
C 5307 V. Vegesack Vol #: 84
C 5308 E. Nakhnikian Vol #: 84
C 5309 D. Clark Vol #: 84
C 5310 C. Tully Vol #: 84
C 5311 D. Wright Vol #: 84
C 5312 I. Haberman Vol #: 84
C 5313 C. Braunshweiger Vol #: 84
C 5314 V. Gordin Vol #: 84
C 5315 J. Endicott Vol #: 84
C 5316 J. Carlson Vol #: 84
C 5317 P. Zukas Vol #: 84
C 5318 R. Cupo Vol #: 84
C 5319 G. Summers Vol #: 84
C 5320 G. Saiacra Vol #: 84
C 5321 M. MacConnell Vol #: 84
C 5322 H. Groves Vol #: 84
C 5323 E. Geddings Vol #: 84
C 5324 R. Fowlkes Vol #: 84
C 5325 N. Washington Vol #: 84
C 5326 A. Cogan Vol #: 84
C 5327 K. Pellissier Vol #: 84
C 5328 M. Knell Vol #: 84
C 5329 P. Nauman Vol #: 84
C 5330 J. Dreiske Vol #: 84
C 5331 A. MArtin Vol #: 84
C 5332 L. Boggs Vol #: 84
C 5333 C. Dougherty Vol #: 84
C 5334 E. Fromberg, DO, FACOOG, DABHM Vol #: 84
C 5335 P. VandeVelde Vol #: 84
C 5336 L. Cuhbertson Vol #: 84
C 5337 R. Rowley Vol #: 84
C 5338 D. Pettitt Vol #: 87
C 5339 P. Leach Vol #: 84
C 5340 J. Wilson Vol #: 84
C 5341 F. Percival Vol #: 84
C 5342 P. McBride Vol #: 84
C 5343 P. McBride Vol #: 84
C 5344 P. McBride Vol #: 84
C 5345 S. Daniel Vol #: 84
C 5346 K. Dark, M.D. Vol #: 84
C 5347 V. Anderson Vol #: 84
C 5348 D. Roth Vol #: 84
C 5349 M. Ewing Vol #: 84
C 5350 E. Stronczer Vol #: 84
C 5351 J. Lisack Vol #: 84
C 5352 P. Landrey Vol #: 84
C 5353 M. Kovalevych Vol #: 84
C 5354 D. Kennedy, PhD Vol #: 84
C 5355 P. Schacher Vol #: 84
C 5356 Dr. P. Cohan Vol #: 84
C 5357 C. Cote, MD Vol #: 84
C 5358 V. Silvestre Vol #: 84
C 5359 J. Worthington Vol #: 84
C 5360 N. Carwile Vol #: 84
C 5361 K. Dixon Vol #: 84
C 5362 C. Starr Vol #: 84
C 5363 J. Johnson Vol #: 84
C 5364 S. Fox Vol #: 84
C 5365 S. Berger Vol #: 84
C 5366 S. Smith Vol #: 84
C 5367 M. Allen Vol #: 84
C 5368 S. Eckfeldt, PhD Vol #: 84
C 5369 S. Allen Vol #: 84
C 5370 J. Darmsted Vol #: 84
C 5371 M. Buhan Vol #: 84
C 5372 K. Bennett Vol #: 84
C 5373 V. Graziadei Vol #: 84
C 5374 L. Ragsdale Vol #: 84
C 5375 S. Bennington Vol #: 84
C 5376 P. Churma Vol #: 84
C 5377 K. Glover Vol #: 84
C 5378 K. Porter Vol #: 84
C 5379 W. Cartozian Vol #: 84
C 5380 P. Hahka Vol #: 84
C 5381 K. Nygard Vol #: 84
C 5382 V. Bent Vol #: 84
C 5383 S. Polk Vol #: 84
C 5384 D. Polk Vol #: 84
C 5385 M. Goldberg Vol #: 84
C 5386 D. Harbin Vol #: 84
C 5387 C. Horne Vol #: 84
C 5388 J. Siegel Vol #: 84
C 5389 B. Hewrioulle Vol #: 84
C 5390 J. Hiester Vol #: 84
C 5391 E. Clark Vol #: 84
C 5392 M. Mahoney Vol #: 84
C 5393 M. Charlesworth Vol #: 84
C 5394 M. McGuckin Vol #: 84
C 5395 S. Campbell Vol #: 84
C 5396 L. Crook Vol #: 87
C 5397 W. Gigliotti Vol #: 84
C 5398 B. Bjorkman Vol #: 84
C 5399 P. Jackson Vol #: 84
C 5400 E. Brown Vol #: 84
C 5401 M. Escobar Vol #: 84
C 5402 T. Darren Vol #: 84
C 5403 P. VanVaketis Vol #: 84
C 5404 S. Hvizdalek Vol #: 84
C 5405 C. Frey Vol #: 84
C 5406 D. Hayes Vol #: 84
C 5407 J. Lerner Vol #: 84
C 5408 L. Lissner Vol #: 84
C 5409 K. Lane Vol #: 84
2006D-0112 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2006D-0128 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions
GDL 1 GUIDANCE Vol #: 1
N 1 FDA Vol #: 1
2006N-0109 General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
NPR 1 FDA Vol #: 1
2006N-0127 Medical Device Reporting; Premarket Approval of Medical Devices; Quality System Regulation; Obstetrical and Gynecological Devices; Ophthalmic Devices; Technical Amendment
NFR 1 FDA Vol #: 1

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