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| Dockets Entered
On July 11, 2006
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 2001D-0220
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| Biological Prod Deviation
Reporting for Blood & Plasma Estab
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| 2003P-0176
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| Follow-On Approval
of Therapeutic Protein Products
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| 2004E-0393
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| Patent Extension for
Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491
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| 2004N-0355
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| Scientific Considerations
Related to Developing Follow-on Protein Products
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| 2004P-0171
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| Standards for 'Similarity'
or 'Sameness' of Biotechnology-Derived Products
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| 2004P-0231
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| Deny approval of NDA
21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection,
lyophilized powder and diluent with preservative
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| 2004P-0329
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| Request Public Hearings
regarding the sales, distribution and use of hand-held Doppler fetoscopes
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| 2005D-0122
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| Guidance for Industry
on Exploratory IND Studies
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| 2005D-0385
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| Guidance for Industry
on Using Electronic Means to Distribute Certain Product Information
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| 2005E-0236
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| Patent Extension Application
for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,916,246
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| 2005N-0437
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| Medical Gas Containers
and Closures; Current Good Manufacturing
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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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| 2006D-0099
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| Class II Special Controls
Guidance Document: Reagents for Detection of Specific Novel Influenza
A Viruses
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| 2006D-0121
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| Guidance for Industry
and Food and Drug Administration: In Vitro Diagnostic Devices to Detect
Influenza A Viruses: Labeling and Regulatory Path
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| 2006D-0172
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| Guidance
for Clinical Investigators, Institutional Review Boards and Sponsors
Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional
Safeguards for Children in Clinical Investigations
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| 2006D-0226
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| Prescription Drug
Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective
Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| 2006E-0025
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| Patent Extension Application
for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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| 2006N-0181
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| Product Stability
Data: Notice of Pilot Project
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| 2006O-0232
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| Over-the-Counter Drug
Products; Safety and Efficacy Review; Additional Laxative Ingredient
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| 2006P-0151
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| Stay the current approvable
letter with conditions of any and all Premarket Applications for silicone
gel-filled breast implants
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| 2006P-0210
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| Amend regulations
for products composed of engineered nanoparticles generally and sunscreen
drug products composed of engineered nanoparticles specifically
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| 2006P-0218
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| To permit an abbrevation
New Drug Application Triamcinolone Diacetate Suspension
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| 2006P-0245
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| Exclusivity Determination
for Risperidone
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| 1978N-0038
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| Sunscreen Drug
Products
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| SUP 35
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| International Center
for Technology Assessment (CTA)
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| Vol #:
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| 150
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| 2001D-0220
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| Biological Prod
Deviation Reporting for Blood & Plasma Estab
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| C 10
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| Plasma Protein Therapeutics
Association (PPTA)
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| Vol #:
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| 1
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| 2003P-0176
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| Follow-On Approval
of Therapeutic Protein Products
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| REF 1
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| References for Citizen
Petition Response
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| Vol #:
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| 4
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| 2004E-0393
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| Patent Extension
for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491
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| C 1
|
| D. Lowe
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| Vol #:
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| 1
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| |
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| 2004N-0355
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| Scientific Considerations
Related to Developing Follow-on Protein Products
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| REF 1
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| References for Citizen Petition
Response
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| Vol #:
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| 21
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| 2004P-0171
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| Standards for 'Similarity'
or 'Sameness' of Biotechnology-Derived Products
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| REF 1
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| References for Citizen Peition
Response
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| Vol #:
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| 4
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| |
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| 2004P-0231
|
| Deny approval of
NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection,
lyophilized powder and diluent with preservative
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| REF 1
|
| References for Citizen Peition
Response
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| Vol #:
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| 5
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| 2004P-0329
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| Request Public
Hearings regarding the sales, distribution and use of hand-held Doppler
fetoscopes
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| PDN 1
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| FDA/CDRH to Russel J. Thomsen,
M.D.
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| Vol #:
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| 3
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| 2005D-0122
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| Guidance for Industry
on Exploratory IND Studies
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| EC 18
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2005D-0385
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| Guidance for Industry
on Using Electronic Means to Distribute Certain Product Information
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| EC 13
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005E-0236
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| Patent Extension
Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No.
4,916,246
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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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| 2005N-0437
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| Medical Gas Containers
and Closures; Current Good Manufacturing
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| C 8
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| Great Plains Homecare Equipement
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| Vol #:
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| 1
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| C 9
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| Barlen and Associates, Inc.
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| Vol #:
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| 1
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| C 10
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| Depke Gases & Welding Supplies,
Inc.
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| Vol #:
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| 1
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| C 11
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| Compressed Gas Association (CGA)
and Gases and Welding Distributors Association (GAWDA)
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| Vol #:
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| 1
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| C 12
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| Four Corners Welding & Gas
Supply (FCWGS)
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| Vol #:
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| 1
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| C 13
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| Albright Welding Supply Co.,
Inc.
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| Vol #:
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| 1
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| C 14
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| Prest-O-Sales & Service,
Inc.
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| Vol #:
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| 1
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| C 15
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| General Distributing, Co.
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| Vol #:
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| 1
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| C 16
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| Buffalo Welding Supply Co.,
Inc.
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| Vol #:
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| 1
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| C 17
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| DeVille Oxygen
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| Vol #:
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| 1
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| C 18
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| DJB Gas Services, Inc.
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| Vol #:
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| 1
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| C 19
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| Oxarc, Inc.
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| Vol #:
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| 1
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| C 20
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| TexAir Welding Supply, Ltd
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| Vol #:
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| 1
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| C 21
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| Oxarc, Inc.
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| Vol #:
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| 1
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| C 22
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| Myco Supply
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| Vol #:
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| 1
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| C 23
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| Oxarc, Inc.
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| Vol #:
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| 1
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| C 24
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| Scott-Gross Company, Inc.
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| Vol #:
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| 1
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| C 25
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| Bemidji Welders Supply
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| Vol #:
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| 1
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|
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|
|
| Clinical Investigations
|
|
|
|
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| EC 2
|
| Pharm Res
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0226
|
| Prescription Drug
Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective
Date and Compliance Policy GuideProgram, Draft Guidance; Availability
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006E-0025
|
| Patent Extension
Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent
No. 5,681,814
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
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| 2006N-0181
|
| Product Stability
Data: Notice of Pilot Project
|
|
|
|
|
| EC 4
|
| Fort Dodge Animal Health
|
| Vol #:
|
| 1
|
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|
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| EC 5
|
| ActivBiotics Inc.
|
| Vol #:
|
| 1
|
|
|
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| 2006O-0232
|
| Over-the-Counter
Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
|
|
|
|
|
| BKG 1
|
| Background Information
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0151
|
| Stay the current
approvable letter with conditions of any and all Premarket Applications
for silicone gel-filled breast implants
|
|
|
|
|
| EC 614
|
| Univ. Mass Medical School
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 615
|
| Ms. Myrl Jeffcoat
|
| Vol #:
|
| 3
|
|
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|
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| EC 616
|
| Mrs. Cindy Fuchs-Morrissey
|
| Vol #:
|
| 3
|
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| EC 617
|
| Ms. Beth Taylor
|
| Vol #:
|
| 3
|
|
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| EC 618
|
| Mrs. Debbie Riffel
|
| Vol #:
|
| 3
|
|
|
|
|
| 2006P-0210
|
| Amend regulations
for products composed of engineered nanoparticles generally and sunscreen
drug products composed of engineered nanoparticles specifically
|
|
|
|
|
| SUP 2
|
| International Center for Technology
Assessment (CTA)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2006P-0218
|
| To permit an abbrevation
New Drug Application Triamcinolone Diacetate Suspension
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0245
|
| Exclusivity Determination
for Risperidone
|
|
|
|
|
| EC 9
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
|
