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| Dockets Entered
On February 23, 2007
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| Docket #
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| Title
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| 1995V-0312
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| Laser Light Show
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| |
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| |
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| 2003E-0402
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| Patent Term Restoration Application for Acrysof, U.S. Patent No. 5,470,932
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| |
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| |
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
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| 2005P-0273
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| Add Calcium to the Mandatory List
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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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| |
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| |
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| 2006D-0514
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| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
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| |
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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-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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| |
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| 2006F-0409
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| Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
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| 2006N-0061
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| Charging for Investigational Drugs
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| 2006P-0094
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| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
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| 2006P-0154
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| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
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| 2006P-0177
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| ANDA Suitability for Methotrexate
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| 2006P-0205
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| Require Vitamin D be added to cereal-grain products
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| 2006P-0346
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| Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. associated with Menopause
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| 2006P-0348
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| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| 2006P-0351
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| Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2007E-0066
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| Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
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| 2007N-0005
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007N-0051
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| Safety of Fresh Produce; Public Hearings
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|
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| 2007P-0065
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| To increase print size of direct-to-consumer advertisements
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|
| |
|
| 1995V-0312
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| Laser Light Show
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| |
|
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| EXP 1
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| Laseronics Design
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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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|
| | | | | | | |
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| |
|
| LET 18864
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| New Chapter, Inc.
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| Vol #:
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| 170
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| |
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| LET 18865
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| Phi-Ten USA, Inc.
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| Vol #:
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| 170
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| |
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| LET 18866
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| Seven Seas Limited
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| Vol #:
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| 170
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| |
|
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| LET 18867
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
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| LET 18868
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
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| LET 18869
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
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| LET 18870
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
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| LET 18871
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18872
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18873
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18874
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18875
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18876
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| PuraPharm Corporation
|
| Vol #:
|
| 170
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| |
|
|
| LET 18877
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18878
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| PuraPharm Corporation
|
| Vol #:
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| 170
|
| |
|
|
| LET 18879
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18880
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18881
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
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| LET 18882
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18883
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18884
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18885
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18886
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18887
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18888
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18889
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
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|
| LET 18890
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18891
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18892
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18893
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18894
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18895
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18896
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18897
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18898
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
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| LET 18899
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18900
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| PuraPharm Corporation
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| Vol #:
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| 170
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|
| | | | | | | |
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| |
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| LET 18901
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18902
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18903
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| PuraPharm Corporation
|
| Vol #:
|
| 170
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| |
|
|
| LET 18904
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| PuraPharm Corporation
|
| Vol #:
|
| 170
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| |
|
|
| LET 18905
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18906
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18907
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18908
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18909
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18910
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| PuraPharm Corporation
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| Vol #:
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| 170
|
| |
|
|
| LET 18911
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18912
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| PuraPharm Corporation
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| Vol #:
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| 170
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| |
|
|
| LET 18913
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18914
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18915
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18916
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18917
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18918
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| PuraPharm Corporation
|
| Vol #:
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| 170
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| |
|
|
| LET 18919
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| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18920
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| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18921
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| PuraPharm Corporation
|
| Vol #:
|
| 170
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| |
|
|
| LET 18922
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18923
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| PuraPharm Corporation
|
| Vol #:
|
| 170
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| |
|
|
| LET 18924
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| PuraPharm Corporation
|
| Vol #:
|
| 170
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| |
|
|
| LET 18925
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18926
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18927
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18928
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18929
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18930
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18931
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18932
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18933
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18934
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18935
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18936
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18937
|
| PuraPharm Corporation
|
| Vol #:
|
| 170
|
|
| | | | | | | | |
|
| |
|
| LET 18938
|
| Smooth Sailing Co.
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18939
|
| Immunotec Research Inc.
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18940
|
| Watkins Incorporated
|
| Vol #:
|
| 170
|
| |
|
|
| LET 18941
|
| Source Naturals
|
| Vol #:
|
| 171
|
| |
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
| |
|
|
| LET 5
|
| K. Ciaston
|
| Vol #:
|
| 580
|
| |
|
|
| 2002P-0122
|
| Request Rulemaking on Functional Foods & Establish Adv. Com.
|
| |
|
|
| C 4
|
| GTC Nutrition
|
| Vol #:
|
| 2
|
| |
|
|
| C 5
|
| Pet Food Institute
|
| Vol #:
|
| 2
|
| |
|
|
| 2003E-0402
|
| Patent Term Restoration Application for Acrysof, U.S. Patent No. 5,470,932
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| C 674
|
| G. Moody
|
| Vol #:
|
| 32
|
| |
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
| |
|
|
| C 542
|
| Number not used
|
| Vol #:
|
| 11
|
| |
|
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
| |
|
|
| C 92
|
| J Gajewski MD
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| Vol #:
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| 10
|
| |
|
|
| C 93
|
| Procter & Gamble Company
|
| Vol #:
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| 10
|
| |
|
|
| C 94
|
| Consumer Healthcare Products Association (CHPA)
|
| Vol #:
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| 10
|
| |
|
|
| C 95
|
| American Society for Blood and Marrow Transplantation (ASBMT)
|
| Vol #:
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| 10
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| |
|
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| EC 27
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| Member of AABB, FACT, and ASQ
|
| Vol #:
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| 4
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| |
|
|
| EC 28
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| DeKalb Medical Center
|
| Vol #:
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| 4
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| |
|
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| EC 29
|
| Cardinal Health, Inc.
|
| Vol #:
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| 4
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| |
|
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| EC 30
|
| Henry Ford Hospital
|
| Vol #:
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| 4
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| |
|
|
| EC 31
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| University of Colorado Cord Blood Bank
|
| Vol #:
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| 4
|
| |
|
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| EC 32
|
| University of Michigan
|
| Vol #:
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| 4
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| |
|
|
| EC 33
|
| Carolinas Medical Center
|
| Vol #:
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| 4
|
| |
|
|
| EC 34
|
| Dr. Stephanie Lee
|
| Vol #:
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| 4
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| |
|
|
| EC 35
|
| UT Southwestern Medical Center
|
| Vol #:
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| 4
|
| |
|
|
| EC 36
|
| University of Colorado Health Science at Denver
|
| Vol #:
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| 4
|
| |
|
|
| EC 37
|
| Stanford University
|
| Vol #:
|
| 4
|
| |
|
|
| EC 38
|
| City of Hope Banner BMT Unit
|
| Vol #:
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| 4
|
|
| | | | | | | | |
|
| |
|
| EC 39
|
| Baylor University Medical Center
|
| Vol #:
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| 4
|
| |
|
|
| EC 40
|
| Baylor College of Medicine
|
| Vol #:
|
| 4
|
| |
|
|
| EC 41
|
| City of Hope
|
| Vol #:
|
| 4
|
| |
|
|
| EC 42
|
| University of Nebraska Medical Center
|
| Vol #:
|
| 4
|
| |
|
|
| EC 43
|
| Baylor University Medical Center
|
| Vol #:
|
| 4
|
| |
|
|
| EC 44
|
| Roswell Park Cancer Institute
|
| Vol #:
|
| 4
|
| |
|
|
| EC 45
|
| Fox Chase-Temple bone Marrow Transpalnt Program
|
| Vol #:
|
| 4
|
| |
|
|
| EC 46
|
| Texas Transplant Institute
|
| Vol #:
|
| 4
|
| |
|
|
| EC 47
|
| University of Chicago
|
| Vol #:
|
| 4
|
| |
|
|
| EC 48
|
|
|
| Vol #:
|
| 4
|
| |
|
|
| EC 49
|
| Fred Hutchinson Cancer Research Center
|
| Vol #:
|
| 4
|
| |
|
|
| EC 50
|
| Ms. Janice Taylor
|
| Vol #:
|
| 4
|
| |
|
|
| EC 51
|
| University of Mississippi Medical Center
|
| Vol #:
|
| 4
|
| |
|
|
| EC 52
|
| National Marrow Donor Program (NMDP)
|
| Vol #:
|
| 4
|
| |
|
|
| 2005P-0273
|
| Add Calcium to the Mandatory List
|
| |
|
|
| SUP 2
|
| Rutgers, State University of New Jersey
|
| Vol #:
|
| 2
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18261
|
| P. Bayliss
|
| Vol #:
|
| 198
|
| |
|
|
| C 18262
|
| K. Blicha
|
| Vol #:
|
| 198
|
| |
|
|
| C 18263
|
| G. Ballard
|
| Vol #:
|
| 198
|
| |
|
|
| C 18264
|
| H. Kerr
|
| Vol #:
|
| 198
|
| |
|
|
| C 18265
|
| T. Durden
|
| Vol #:
|
| 198
|
| |
|
|
| C 18266
|
| J. Stephens
|
| Vol #:
|
| 198
|
| |
|
|
| C 18267
|
| H. Brock
|
| Vol #:
|
| 198
|
| |
|
|
| C 18268
|
| L. McCown
|
| Vol #:
|
| 198
|
| |
|
|
| C 18269
|
| E. McConnell
|
| Vol #:
|
| 198
|
| |
|
|
| C 18270
|
| C. McLaughlin
|
| Vol #:
|
| 198
|
| |
|
|
| C 18271
|
| D. Shephard
|
| Vol #:
|
| 198
|
| |
|
|
| C 18272
|
| B. Grindle
|
| Vol #:
|
| 198
|
| |
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| C 4
|
| College of American Pathologists
|
| Vol #:
|
| 1
|
| |
|
|
| C 5
|
| American Association for Clinical Chemistry (AACC)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0514
|
| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
|
|
|
|
|
|
|
|
| | | | | | | | |
|
| |
|
| C 1
|
| St. Charles Mercy Hospital
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0034
|
| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
|
| |
|
|
| LET 4
|
| Number not used
|
| Vol #:
|
| 1
|
|
| |
|
| 2006E-0240
|
| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
|
| |
|
|
| LET 4
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0354
|
| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006F-0409
|
| Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
|
| |
|
|
| C 3
|
| B Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0061
|
| Charging for Investigational Drugs
|
| |
|
|
| C 4
|
| Pfizer Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0464
|
| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
|
| |
|
|
| C 3
|
| BioMarin Pharmaceutical, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| C 4
|
| Neurogen Corporation
|
| Vol #:
|
| 2
|
| |
|
|
| C 5
|
| Medtronic, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| C 6
|
| Wyeth Pharmaceuticals, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0094
|
| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
|
|
|
|
|
|
|
| |
|
|
| C 6
|
| Oregon Rasberry & Blackberry Commission
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0154
|
| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
|
| |
|
|
| REF 1
|
| References to PDN1
|
| Vol #:
|
| 4
|
|
| |
|
| 2006P-0177
|
| ANDA Suitability for Methotrexate
|
| |
|
|
| WDL 1
|
| Teva Sicor Pharmaceuticals Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0205
|
| Require Vitamin D be added to cereal-grain products
|
| |
|
|
| SUP 2
|
| Rutgers, State University of New Jersey
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0346
|
| Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. associated with Menopause
|
| |
|
|
| LET 1
|
| FDA/CDER to National Women's Health Network
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0348
|
| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
|
|
|
|
|
|
|
| |
|
|
| LET 1
|
| FDA/CDER to Clinical and Laboratory Standards Institute
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006P-0351
|
| Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions
|
| |
|
|
| LET 1
|
| University of Florida
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| C 52
|
| B Newman
|
| Vol #:
|
| 6
|
| |
|
|
| C 53
|
| M Pinoles
|
| Vol #:
|
| 6
|
| |
|
|
| 2007E-0066
|
| Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
|
| |
|
|
| APP 1
|
| Schering Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0005
|
| Prescription Drug User Fee Act (PDUFA): Public Meeting
|
| |
|
|
| C 1
|
| National Health Council
|
| Vol #:
|
| 2
|
| |
|
|
| TS 21
|
| Friends of Cancer Research
|
| Vol #:
|
| 2
|
| |
|
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| EAPE 262
|
| Hackett, Donald
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 263
|
| Wencel, Holly
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 264
|
| Kelser, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 265
|
| McAdams, Mara
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 266
|
| Iyasu, Solomon
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0051
|
| Safety of Fresh Produce; Public Hearings
|
| |
|
|
| NHC 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0065
|
| To increase print size of direct-to-consumer advertisements
|
| |
|
|
| ACK 1
|
| FDA/DDM to Pharmacists Planning Service, Inc.
|
| Vol #:
|
| 1
|
|
|
