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| Dockets Entered
On September 6, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1998D-0307
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| Exports/Imports under FDA export reform/enhancement Act 1996
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| 1998D-1232
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| Points to Consider Guidance Documents on Assayed & Unassayed Quality Control Material
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| 1999D-1651
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| Chemistry,Mfging/Control Changes to an approved NADA/ANADA
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004N-0234
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| Annual Guidance Agenda
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| 2004V-0537
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| Projector for a Laser Light Show
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| 2006D-0451
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| Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers
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| 2006N-0292
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| Unique Device Identification
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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-0071
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| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
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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-0125
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| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
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| 2007D-0212
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| Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
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| 2007D-0233
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| Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
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| 2007N-0218
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program)
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| 2007N-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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| 2007N-0329
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| Determination That Miltown (meprobamate) Tablets and 5 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| 2007P-0275
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| To permit an ANDA Suitability for Nabumetone Tablets 1000 mg
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0333
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| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
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| 2007P-0336
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| To permit an ANDA Suitability for RitonavirTablets, 100 mg
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| 2007V-0141
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| Laser Light Show
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2226
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| Ms. Jessica Cooper
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| Vol #:
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| 161
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| EC 2227
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| Mrs. Lisa Peppard
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| Vol #:
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| 161
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| EC 2228
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| Ms. Robin Sloan
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| Vol #:
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| 161
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| EC 2229
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| Mrs. Dena Baylor
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| Vol #:
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| 161
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| EC 2230
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| Mrs. clotilde siciliano
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| Vol #:
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| 161
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| EC 2231
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| Ms. Nancy McRae
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| Vol #:
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| 161
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| EC 2232
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| Mrs. Tina Richards
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| Vol #:
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| 161
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| EC 22
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| Mrs. christie carter
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| Vol #:
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| 2
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| 2004N-0234
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| Annual Guidance Agenda
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| EC 8
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| Ms. Julia Tucker
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| Vol #:
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| 1
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| 2004V-0537
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| Projector for a Laser Light Show
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| LET 1
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| FDA/CDRH
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| Vol #:
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| 1
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| 2006D-0451
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| Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers
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| EC 7
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| Miss. Tchaika fleuranvil
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| C 30
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| American Hospital Association
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| Vol #:
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| 4
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| EREG 1
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| J. Walsh
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| Vol #:
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| 19
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| 2006P-0071
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| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
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| EC 1
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| Stanford University
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| Vol #:
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| 2
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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 142
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| F Goldman
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| Vol #:
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| 7
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| C 143
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| ALP INC
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| Vol #:
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| 7
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| 2007D-0125
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| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
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| EC 2302
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| Ms. Tracy Carroll
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| Vol #:
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| 18
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| EC 2303
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| Salt Institute
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| Vol #:
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| 18
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| EC 2304
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| Mr. Joseph Bianculli
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| Vol #:
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| 18
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| EC 2305
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| Mr. James Rossin
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| Vol #:
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| 18
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| EC 2306
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| Mrs. Dana Luchini
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| Vol #:
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| 18
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| EC 2307
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| Mrs. melody henderson
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| Vol #:
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| 18
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| EC 2308
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| Mrs. Diane Pellegrini
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| Vol #:
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| 18
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| EC 2309
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| Mr. Dennis DiPerre
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| Vol #:
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| 18
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| EC 2310
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| Dr. Sy Brandon
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| Vol #:
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| 18
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| EC 2311
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| Ms. Maureen Shepard
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| Vol #:
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| 18
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| EC 2312
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| Mrs. Tara Gesling
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| Vol #:
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| 18
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| EC 2313
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| Ms. Marguerite Rooney
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| Vol #:
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| 18
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| EC 2314
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| Ms. Sharon Butler
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| Vol #:
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| 18
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| EC 2315
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| Bauman College
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| Vol #:
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| 18
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| EC 2316
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| Mr. David Uttal
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| Vol #:
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| 18
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| EC 2317
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| Mr. Tim Wilson
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| Vol #:
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| 18
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| EC 2318
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| Ms. Meaghan Hendrickson
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| Vol #:
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| 18
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| EC 2319
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| Mrs. Jearldean Shinn
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| Vol #:
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| 18
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| EC 2320
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| Vol #:
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| 18
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| EC 2321
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| Ms. Toni Mudd
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| Vol #:
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| 18
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| EC 2322
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| Mrs. Janis Karabats
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| Vol #:
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| 18
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| EC 2323
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| Ms. Marnie McNulty
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| Vol #:
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| 18
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| EC 2324
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| Mr. Arthur Karabats
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| Vol #:
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| 18
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| EC 2325
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| Mr. Leopold Zappler
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| Vol #:
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| 18
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| EC 2326
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| Ms. Mona Burns
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| Vol #:
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| 18
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| EREG 1
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| C. Adamo
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| Vol #:
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| 18
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| EREG 2
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| C. Riggio
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| Vol #:
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| 18
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| EREG 3
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| D. Edens
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| Vol #:
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| 18
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| EREG 4
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| J. Schwaiger
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| Vol #:
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| 18
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| 2007D-0212
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| Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
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| C 2
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| Sanofi Aventis
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| Vol #:
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| 1
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| 2007D-0233
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| Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
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| EC 2
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| GlaxoSmithKline
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| Vol #:
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| 1
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| 2007N-0218
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program)
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2007N-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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| BKG 1
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| Background Material
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| Vol #:
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| 1
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| 2007N-0329
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| Determination That Miltown (meprobamate) Tablets and 5 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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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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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| LET 2
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| FDA
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| Vol #:
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| 1
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| 2007P-0275
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| To permit an ANDA Suitability for Nabumetone Tablets 1000 mg
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| EC 1
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| Ms. michelle penn
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| Vol #:
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| 1
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| EC 17
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| University of Vermont - Student
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| Vol #:
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| 1
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| EC 18
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| Mr. Blane King
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| Vol #:
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| 1
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| C 2
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| A Mass
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| Vol #:
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| 1
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| C 3
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| F Fassett
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| Vol #:
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| 1
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| C 4
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| P. Haider
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| Vol #:
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| 1
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| C 5
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| M. Kearney
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| Vol #:
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| 1
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| 2007P-0333
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| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
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| ACK 2
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| FDA/DDM to Dwight G. Castle
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| Vol #:
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| 1
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| CP 2
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| Dwight G. Castle
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| Vol #:
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| 1
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| 2007P-0336
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| To permit an ANDA Suitability for RitonavirTablets, 100 mg
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| ACK 1
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| Matrix Laboratories, Inc.
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| Vol #:
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| 1
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| CP 1
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| Matrix Laboratories, Inc.
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| Vol #:
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| 1
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| 2007V-0141
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| Laser Light Show
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| LET 1
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| FDA/CDRH
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| Vol #:
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| 1
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