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Dockets Management

Dockets Entered On July 26, 2007
Docket # Title
1981P-0001 Laser Lumia Projection System
1985V-0189 Laser Light Show
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
1999V-0185 Variance Laser Light Show LT-1000
2005P-0076 OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0212 Lasik due to the use of research from experiments conducted on human beings without proper basis to believe it is in the patients best interests and improper patient informed consent
2006P-0213 enforce the single-use requirement for all Microkeratomes and their components used by Lasik
2006P-0518 Stop all approvals of medical devices and their components used for LASIK or place a moratorium on their use
2006P-0519 Stop all approvals of medical devices used for implantable lens implants including, but not limited to Phakic IOLs (PIOLs) and Collamar Lenses or to place a moratorium on their use
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
2007P-0094 Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the- counter
1981P-0001 Laser Lumia Projection System
VRA 15 Lynne L. Rice Vol #: 1
1985V-0189 Laser Light Show
VRA 14 Lynne L. Rice Vol #: 1
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 401 Guizhou Runfeng Natural Roborants Co., Ltd. Vol #: 314
RPT 402 Ajinomoto U.S.A., Inc. Vol #: 315
RPT 403 Bionov Vol #: 314
RPT 404 Sunbio Corporation Vol #: 314
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
PRC 1 American Herbal Products Association Vol #: 43
1999V-0185 Variance Laser Light Show LT-1000
VRA 4 Lynne L. Rice Vol #: 1
2005P-0076 OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
LET 2 Reps. Harold Rogers and Frank Wolf Vol #: 1
LET 3 Stephen R. Mason, FDA Vol #: 1
LET 4 Stephen R. Mason, FDA Vol #: 1
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
C 26 Merck & Co., Inc. Vol #: 1
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 8 Dr. Sark S. Derderian, USAMC (Ret) Vol #: 1
C 9 Patricia Dilauro, Coordinator - Pulmonary Rehab Program Vol #: 1
C 10 Ms. Donna Breining Vol #: 1
C 11 David C. Levin, M.D. Vol #: 1
C 12 Frank R. Salvatore Jr., BS, RRT, FAARC Vol #: 1
C 13 Richard P. Imbruce, PH.D. Vol #: 1
C 14 Arthur Kneller Vol #: 1
C 15 Anthony Vumbaco Vol #: 1
C 16 Arthur J. Bridges Vol #: 1
C 17 Mrs. Wilbur H. Smith Vol #: 1
C 18 Steven H. Bernhardt, Ph.D. Vol #: 1
C 19 Wlodzimierz 'Vlady' Rozenbaum, Ph.D. Vol #: 1
C 20 Nadine L. Killian Vol #: 1
C 21 Steven and Rozella Jones Vol #: 1
C 22 Susan Ashlee and Andrew Melito Vol #: 1
2006P-0212 Lasik due to the use of research from experiments conducted on human beings without proper basis to believe it is in the patients best interests and improper patient informed consent
PDN 1 FDA/CDRH to Michael Patterson, Ph.D., BSEE Vol #: 1
2006P-0213 enforce the single-use requirement for all Microkeratomes and their components used by Lasik
PDN 1 FDA/CDRH to Michael Patterson, Ph.D., BSEE Vol #: 1
2006P-0518 Stop all approvals of medical devices and their components used for LASIK or place a moratorium on their use
PDN 1 FDA/CDRH to Michael Patterson, Ph.D., BSEE Vol #: 1
2006P-0519 Stop all approvals of medical devices used for implantable lens implants including, but not limited to Phakic IOLs (PIOLs) and Collamar Lenses or to place a moratorium on their use
PDN 1 FDA/CDRH to Michael Patterson, Ph.D., BSEE Vol #: 1
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
C 186 Rachel Blunk Vol #: 6
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 1 Consumers Union Vol #: 1

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