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Dockets Management

Dockets Entered On January 7, 2008
Docket # Title
1978N-0038 Sunscreen Drug Products
1994D-0025 Guidelines on the Voluntary Labeling Milk & Milk Products from Cows That Have Not Been Treated with rbSt or rbGH
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2005P-0433 Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
2006N-0466 Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007D-0364 Impact-Resistant Lenses: Questions and Answers Guidance
2007D-0367 Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
2007D-0419 Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
2007H-0433 Civil Money Penalty; Advanced Bionics Corporation
2007N-0280 Amendment to the CGMP Regulations for Finished Pharmaceuticals
2007N-0485 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
2007N-0487 Meeting being planned to obtain public input for ensuring the safety of pet food
2007N-0489 Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments
2007P-0331 Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic
2008P-0006 To determine whether Didrex 25 mg (benzphetmine hydrochloride) Tablets (NDA 12-427) by Pharmacia and Upjohn Company, has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
2008P-0010 Over-the-Counter (OTC) Pertaining to Cough/Cold Drug Products Containg Tannates
2008V-0008 Laser Light Show
1978N-0038 Sunscreen Drug Products
C 726 Duke Surgery, Duke University Medical Center Vol #: 182
1994D-0025 Guidelines on the Voluntary Labeling Milk & Milk Products from Cows That Have Not Been Treated with rbSt or rbGH
ANS 12 FDA/Executive Secretariat to Robert & Mary Fuhs Vol #: 71
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 21271 Isaac Marcum Vol #: 183
LET 21272 Isaac Marcum Vol #: 183
LET 21273 Isaac Marcum Vol #: 183
LET 21274 Isaac Marcum Vol #: 183
LET 21275 Isaac Marcum Vol #: 183
LET 21276 Isaac Marcum Vol #: 183
LET 21277 Isaac Marcum Vol #: 183
LET 21278 Isaac Marcum Vol #: 183
LET 21279 Isaac Marcum Vol #: 183
LET 21280 Isaac Marcum Vol #: 183
LET 21281 Isaac Marcum Vol #: 183
LET 21282 Isaac Marcum Vol #: 183
LET 21283 Isaac Marcum Vol #: 183
LET 21284 Isaac Marcum Vol #: 183
LET 21285 Isaac Marcum Vol #: 183
LET 21286 Isaac Marcum Vol #: 183
LET 21287 Isaac Marcum Vol #: 183
LET 21288 Isaac Marcum Vol #: 183
LET 21289 Isaac Marcum Vol #: 183
LET 21290 Isaac Marcum Vol #: 183
LET 21291 Isaac Marcum Vol #: 183
LET 21292 Isaac Marcum Vol #: 183
LET 21293 Isaac Marcum Vol #: 183
LET 21294 Isaac Marcum Vol #: 183
LET 21295 Isaac Marcum Vol #: 183
2005P-0433 Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
C 9 Natural Solutions Foundation Vol #: 2
C 10 Natural Solutions Foundation Vol #: 3
C 11 Natural Solutions Foundation Vol #: 4
C 12 Natural Solutions Foundation Vol #: 5
C 13 Natural Solutions Foundation Vol #: 6
2006N-0466 Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
EREG 1 J. Breen Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 525 D. Baker Vol #: 14
2007D-0364 Impact-Resistant Lenses: Questions and Answers Guidance
EC 16 Spectacles Vol #: 1
EC 17 Professional Optician of Florida Vol #: 1
EC 18 Mr. Alan Rubin Vol #: 1
EC 19 Durham Optical Vol #: 1
EC 20 Professional Opticians of Florida Vol #: 1
EC 21 Mr. Gary Harris Vol #: 1
2007D-0367 Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
NEC 1 FDA Vol #: 1
2007D-0419 Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance
C 1 Sanofi Aventis Vol #: 1
2007H-0433 Civil Money Penalty; Advanced Bionics Corporation
CS 2 FDA/DDM Vol #: 1
OR 2 FDA/Administrative Law Judge Vol #: 1
2007N-0280 Amendment to the CGMP Regulations for Finished Pharmaceuticals
EREG 1 M. Jornitz Vol #: 1
2007N-0485 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
N 1 FDA Vol #: 1
2007N-0487 Meeting being planned to obtain public input for ensuring the safety of pet food
N 1 FDA Vol #: 1
2007N-0489 Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments
N 1 FDA Vol #: 1
2007P-0331 Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic
EC 12 Fresno City College Student Vol #: 2
2008P-0006 To determine whether Didrex 25 mg (benzphetmine hydrochloride) Tablets (NDA 12-427) by Pharmacia and Upjohn Company, has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
ACK 1 FDA/ DDM to Lachman Consultant Services, Inc. Vol #: 1
CP 1 Lachman Consultant Services, Inc. Vol #: 1
2008P-0010 Over-the-Counter (OTC) Pertaining to Cough/Cold Drug Products Containg Tannates
ACK 1 FDA/ DDM to Tannates Working Group Vol #: 1
CP 1 Tannates Working Group Vol #: 1
2008V-0008 Laser Light Show
ACK 1 FDA/ DDM to See Touring Productions, Inc. Vol #: 1
VAR 1 See Touring Productions, Inc. Vol #: 1

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