| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On October 25, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 1999N-2337
|
| GMP for Blood & Blood Components;Increased Risk of Transmiti
|
|
|
|
|
| 2005P-0501
|
| Revise FDA's guidance entitled labeling for combined oral contraeceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disease
|
|
|
|
|
| 2006N-0278
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develo
|
|
|
|
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| 2007D-0168
|
| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
|
|
|
|
|
| 2007D-0387
|
| Guidance for Industry and FDA Staff; In Vitro Diagnostic Device Studies Frequently Asked Questions
|
|
|
|
|
| 2007D-0396
|
| Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation
|
|
|
|
|
| 2007N-0186
|
| 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
|
|
|
|
|
|
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| 2007N-0382
|
| Ramipril Capsules and 180-day generic drug exclusivity
|
|
|
|
|
| 2007N-0389
|
| Granisetron Hydrochloride Injection and 180-day generic drug exclusivity
|
|
|
|
|
| 2007N-0390
|
| User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Request for Notification of Participation and Number of Advertisemen
|
|
|
|
|
|
| 2007P-0116
|
| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
|
|
|
|
|
| 2007P-0171
|
| Not delist U.S. patent 4,879,303 (the 303 patent) for Norvasc amlodipine besylate product
|
|
|
|
|
| 2007P-0210
|
| Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C
|
|
|
|
|
| 2007P-0235
|
| Change the labeling requirements for eggs sold in the United States
|
|
|
|
|
| 2007P-0414
|
| Stay approval of any and all subsequent abbreviated new drug applications (ANDAs) for Acarbose Tablets 25mg, 50 mg, and 100 mg..
|
|
| |
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| C 617
|
| Karl Kiklis Melanoma Education Fund
|
| Vol #:
|
| 162
|
|
|
|
|
| EXT 14
|
| Procter & Gamble
|
| Vol #:
|
| 162
|
|
|
|
|
| LET 182
|
| H. Russell Potts, Jr.,
Member 27th Senate of Virginia
|
| Vol #:
|
| 162
|
|
|
|
|
| 1999N-2337
|
| GMP for Blood & Blood
Components; Increased Risk of Transmiti
|
|
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 3
|
|
|
|
|
| SS 1
|
| FDA
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005P-0501
|
| Revise FDA's guidance entitled labeling for combined oral contraeceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disease
|
|
|
|
|
|
| |
|
|
|
| LET 2
|
| HYMAN, PHELPS & McNAMARA, P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0278
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develo
|
|
|
|
|
|
| |
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| C 4246
|
| L. Seeman
|
| Vol #:
|
| 40
|
|
|
|
|
| C 4247
|
| E. L. Fox
|
| Vol #:
|
| 40
|
|
|
|
|
| C 4248
|
| B. Moore
|
| Vol #:
|
| 40
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| C 461
|
| S. Bamett
|
| Vol #:
|
| 12
|
|
|
|
|
| C 462
|
| L. Barnwell
|
| Vol #:
|
| 12
|
|
|
|
|
| C 463
|
| K. Nicoley
|
| Vol #:
|
| 12
|
|
|
|
|
| C 464
|
| R. Malone
|
| Vol #:
|
| 12
|
|
|
|
|
| C 465
|
| S. Patel
|
| Vol #:
|
| 12
|
|
|
|
|
| C 466
|
| Unknown
|
| Vol #:
|
| 12
|
|
|
|
|
| C 467
|
| M. Clemetson
|
| Vol #:
|
| 12
|
|
|
|
|
| C 468
|
| J. Poliseno
|
| Vol #:
|
| 12
|
|
|
|
|
| C 469
|
| B. D. Mayerman
|
| Vol #:
|
| 12
|
|
|
|
|
| C 470
|
| D. Martin
|
| Vol #:
|
| 12
|
|
|
|
|
| C 471
|
| S. Scott
|
| Vol #:
|
| 12
|
|
|
|
|
| C 472
|
| M. Franklin
|
| Vol #:
|
| 12
|
|
|
|
|
| C 473
|
| B. Mott
|
| Vol #:
|
| 12
|
|
|
|
|
| 2007D-0168
|
| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
|
|
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0387
|
| Guidance for Industry and FDA Staff; In Vitro Diagnostic Device Studies Frequently Asked Questions
|
|
|
|
|
| GDL 1
|
| FDA/CDRH/CBER
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0396
|
| Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation
|
|
|
|
|
| GDL 1
|
| FDA/CDER/CBER
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0186
|
| 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
|
|
|
|
|
|
| |
|
|
|
| C 3
|
| American Herbal Products Association
|
| Vol #:
|
| 1
|
|
|
|
|
| C 4
|
| Natural Products Association
|
| Vol #:
|
| 1
|
|
|
|
|
| EREG 4
|
| S. de Mars
|
| Vol #:
|
| 1
|
|
|
|
|
| SUP 1
|
| Natural Products Association
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0356
|
| Behind The Counter
Availability of Certain Drugs; Public Meeting
|
|
| | | | | | | | |
|
| |
|
| EAPE 186
|
| Johnson & Johnson Consumer Companies
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 187
|
| OBAGI Medical Products
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 188
|
| OBAGI Medical Products
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 189
|
| American Dietetic Assn
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 190
|
| Mount Sinai Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0382
|
| Ramipril Capsules and 180-day generic drug exclusivity
|
|
|
|
|
| C 4
|
| N. Tantillo
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0389
|
| Granisetron Hydrochloride Injection and 180-day generic drug exclusivity
|
|
|
|
|
| C 1
|
| Winston & Strawn LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0390
|
| User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Request for Notification of Participation and Number of Advertisemen
|
|
|
|
|
|
| |
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0116
|
| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
|
|
|
|
|
|
| |
|
|
|
| LET 3
|
| Randall W. Lutter
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0171
|
| Not delist U.S. patent 4,879,303 (the 303 patent) for Norvasc amlodipine besylate product
|
|
|
|
|
| LET 1
|
| Randall W. Lutter
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0210
|
| Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C
|
|
|
|
|
| LET 2
|
| HiFi DNA Tech, LLC
|
| Vol #:
|
| 5
|
|
|
|
|
| 2007P-0235
|
| Change the labeling requirements for eggs sold in the United States
|
|
|
|
|
| C 234
|
| S. Bamett
|
| Vol #:
|
| 4
|
|
|
|
|
| C 235
|
| L. Barnwell
|
| Vol #:
|
| 4
|
|
|
|
|
| C 236
|
| K. Nicoley
|
| Vol #:
|
| 4
|
|
|
|
|
| C 237
|
| R. Malone
|
| Vol #:
|
| 4
|
|
|
|
|
| C 238
|
| S. Patel
|
| Vol #:
|
| 4
|
|
|
|
|
| C 239
|
| Unknown
|
| Vol #:
|
| 4
|
|
|
|
|
| C 240
|
| M. Clemetson
|
| Vol #:
|
| 4
|
|
|
|
|
| C 241
|
| J. Poliseno
|
| Vol #:
|
| 4
|
|
|
|
|
| C 242
|
| B. D. Mayerman
|
| Vol #:
|
| 4
|
|
|
|
|
| C 243
|
| D. Martin
|
| Vol #:
|
| 4
|
|
|
|
|
| C 244
|
| S. Scott
|
| Vol #:
|
| 4
|
|
|
|
|
| C 245
|
| M. Franklin
|
| Vol #:
|
| 4
|
|
|
|
|
| C 246
|
| B. Mott
|
| Vol #:
|
| 4
|
|
