| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On December 13, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing & Handling of Food
|
|
|
|
|
| 2005P-0182
|
| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
|
|
|
|
|
| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| 2006N-0168
|
| Food Labeling: Reference Daily Intakes & Daily Reference Values
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| 2007D-0364
|
| Impact-Resistant Lenses: Questions and Answers Guidance
|
|
|
|
|
| 2007D-0365
|
| Guidance for Industry on The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 Current Good Manufacturing Practice (CGMP)
|
|
|
|
|
| 2007N-0348
|
| Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza
|
|
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| 2007N-0382
|
| Ramipril Capsules and 180-day generic drug exclusivity
|
|
|
|
|
| 2007P-0094
|
| Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the- counter
|
|
|
|
|
|
|
|
|
| 2007P-0250
|
| Enact stricter guidelines in prescribing methadone for any reason
|
|
|
|
|
| 2007P-0251
|
| Petition for a policy statement requiring that all future advisory committee meetings discussing specific products include an oral scientific presentation by FDA staff on the products reviewed, includ
|
|
|
|
|
|
|
|
|
| 2007P-0320
|
| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
|
|
| |
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| C 711
|
| TRI-K Industries
|
| Vol #:
|
| 176
|
|
|
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing & Handling of Food
|
|
|
|
|
| C 3752
|
| R. Shapiro
|
| Vol #:
|
| 61
|
|
|
|
|
| 2005P-0182
|
| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
|
|
|
|
|
| PDN 1
|
| J. Shuren, Assistant Commissioner for Policy
|
| Vol #:
|
| 2
|
|
| |
|
| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
|
|
|
|
|
| EC 36
|
| Imperial College London
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 37
|
| Mr. John Rowe
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 38
|
| Medical School
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| SUP 1
|
| American Clinical Laboratory Association
|
| Vol #:
|
| 5
|
|
|
|
|
| 2006N-0168
|
| Food Labeling: Reference Daily Intakes & Daily Reference Values
|
|
|
|
|
| EXT 2
|
| International Food Additives Council
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT 3
|
| The Calorie Control Council
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| C 4271
|
| D. M. Bunnell
|
| Vol #:
|
| 40
|
|
|
|
|
| C 4272
|
| B. S. Zipkin
|
| Vol #:
|
| 40
|
|
|
|
|
| C 4273
|
| E. M. Wicke
|
| Vol #:
|
| 40
|
|
|
|
|
| 2007D-0364
|
| Impact-Resistant Lenses: Questions and Answers Guidance
|
|
|
|
|
| EC 13
|
| Miss. Denise Cook
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| Ben Taylor Optical
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0365
|
| Guidance for Industry on The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 Current Good Manufacturing Practice (CGMP)
|
|
|
|
|
| C 1
|
| LEAP Technologies, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CR 1
|
| Takao Manufacturing Co., LTD
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0348
|
| Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza
|
|
|
|
|
| C 1
|
| NOVARTIS
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| EC 126
|
| North Carolina Association of Pharmacists
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 127
|
| Mrs. Amy Smendik
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 128
|
| NEOUCOM / NEOUCOP
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 129
|
| GlaxoSmithKline Consumer Healthcare
|
| Vol #:
|
| 2
|
|
|
|
|
| 2007N-0382
|
| Ramipril Capsules and 180-day generic drug exclusivity
|
|
|
|
|
| LET 5
|
| FOLEY & LARDNER LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0094
|
| Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the-counter
|
|
|
|
|
|
| |
|
|
|
| C 3
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0250
|
| Enact stricter guidelines in prescribing methadone for any reason
|
|
|
|
|
| LET 1
|
| J. A. Axelrad
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0251
|
| Petition for a policy statement requiring that all future advisory committee meetings discussing specific products include an oral scientific presentation by FDA staff on the products reviewed, includ
|
|
|
|
|
|
| |
|
|
|
| LET 1
|
| J. A. Axelrad
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0320
|
| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
|
|
|
|
|
| EC 21
|
| Ms. Katie Bekker
|
| Vol #:
|
| 1
|
|
