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| Dockets Entered
On January 24, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| 2001D-0269
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| Clinical Studies Section for Prescription Drugs & Biologics
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0296
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical Studies (21 CFR Part 58)
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| 2005D-0362
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| Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
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| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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| 2005N-0396
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| Agency Information Collection Activities: Proposed Collection; Guidance on Formal Dispute Resolution; Appeals Above the Division Level
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
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| 2005P-0291
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| ANDA or Section 505(b)(2),for inhalation drug products containing a combination of active ingredients albuterol sulfate and ipratropium hydrochloride
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0417
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| ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| 2006N-0021
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
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| 2006P-0047
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| Refrain from Approval any ANDA for Celestone Soluspan
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| 2006P-0049
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| reduce the public health risks associated with the use of drugs manufactured or processed at foreign facilities
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| 2006V-0048
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
17166
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| Pharmanex, LLC
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| Vol #:
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| 156
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| LET
17167
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| RKS Inc.
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| Vol #:
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| 156
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| LET
17168
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| R.A.M. Biotechnologyu Researches Ltd.
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| Vol #:
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| 156
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| LET
17169
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| American Healing Technologies, Inc.
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| Vol #:
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| 156
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| LET
17170
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| American Healing Technologies, Inc.
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| Vol #:
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| 156
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| LET
17171
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| Nature's Way Products, Inc.
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| Vol #:
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| 156
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| LET
17172
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| Enzymatic Therapy
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| Vol #:
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| 156
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| LET
17173
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| Ezymatic Therapy
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| Vol #:
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| 156
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| NFR
1
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| FDA
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| Vol #:
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| 7
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| 2001D-0269
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| Clinical Studies Section for Prescription Drugs & Biologics
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| C
3
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| Guttmacher Institute
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| Vol #:
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| MO 16
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| GCF-1 and Ecumed Helaht Group, Amador Reyes, Juan C. Carrai, Richard W. Stone, Erlinda E. Enri
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| Vol #:
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| 10
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| 2004N-0296
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical Studies (21 CFR Part 58)
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| C 14
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| J. Rotten
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| Vol #:
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| 1
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| GDL
1
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| Guidance: Labeling for Human Prescription Drug and Biological Products -- Implementing the New Content and Format Requirements
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| Vol #:
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| 1
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| GDL
2
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| Guidance: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Productgs -- Content and Format
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005D-0362
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| Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
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| C
1
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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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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| 2005N-0396
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| Agency Information Collection Activities: Proposed Collection; Guidance on Formal Dispute Resolution; Appeals Above the Division Level
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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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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
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| EMC
4
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| Food and Drug Administration
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| Vol #:
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| 3
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| 2005P-0291
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| ANDA or Section 505(b)(2),for inhalation drug products containing a combination of active ingredients albuterol sulfate and ipratropium hydrochloride
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| LET
1
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| HFD-005 to Frommer Lawrence and Haug LLP
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 396
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| J. Shultz
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| Vol #:
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| 5
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| C 397
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| L.Watson
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| Vol #:
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| 5
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| C 398
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| V. Yazzie
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| Vol #:
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| 5
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| C 399
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| M. Barknight
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| Vol #:
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| 5
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| C 400
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| M. Poppe
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| Vol #:
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| 5
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| C 401
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| D. Petersen
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| Vol #:
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| 5
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| C 402
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| L. Watts
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| Vol #:
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| 5
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| C 403
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| D. Poe,RN
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| Vol #:
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| 5
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| C 404
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| A. Lather
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| Vol #:
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| 5
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| C 405
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| T. Montague
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| Vol #:
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| 5
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| C 406
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| L. Chapman
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| Vol #:
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| 5
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| C 407
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| J. Bauer
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| Vol #:
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| 5
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| C 408
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| M. Wilkey
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| Vol #:
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| 5
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| C 409
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| C. Helwig
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| Vol #:
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| 5
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| C 410
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| C. Barton
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| Vol #:
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| 5
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| 2005P-0417
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| ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%
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| SUP
1
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| Triax Pharmaceuticals, LLC
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| Vol #:
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| 2
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| C
1
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| Wyeth Pharmaceuticals
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| Vol #:
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| 2
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| C
1
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| Cardinal Health Medical Products and Services (Cardinal)
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| Vol #:
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| 1
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| |
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| 2006N-0021
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
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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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| 2006P-0047
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| Refrain from Approval any ANDA for Celestone Soluspan
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| ACK
1
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| HFA-305 to SPEC Pharma
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| Vol #:
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| 1
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| CP
1
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| SPEC Pharma
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| Vol #:
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| 1
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| 2006P-0049
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| reduce the public health risks associated with the use of drugs manufactured or processed at foreign facilities
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| CP
1
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| Synthetic Organic Chemical Manufacturers Association's
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| Vol #:
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| 1
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| 2006V-0048
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| Laser Light Show
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| ACK
1
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| HFA-305 to TIA Products
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| Vol #:
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| 1
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| VAR
1
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| TIA Products
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| Vol #:
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| 1
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