Dockets Entered on March 15, 2005

Dockets Management



Dockets Entered On March 15, 2005 Table of Contents



Docket #	Title

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

2000N-1596	Uniform Compliance Date for Food Labeling Regulations

2003D-0167	Draft Guidance for Industry on Dispute Resolution Procedures for Science-based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability

2003D-0386	Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

2003P-0029	Remove metered-dose inhalers (MDI) containing moiety albuter

2004N-0181	Critical Path Initiative

2004N-0527	Medical Devices; Medical Device Reporting

2004N-0535	Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request

2004N-0559	Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents

2004P-0113	immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur

2004P-0329	Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes

2004P-0417	ANDA Doryx (coated doxycycline hyclate pellets) in powder or other fill present

2005N-0083	Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics

2005P-0104	Determine whether Peptavlon (pentagastrin) was voluntarily withdrawn from sale for reasons other than safety or effectiveness

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary
LET 15644	NBTY Inc.	Vol #:	138

LET 15645	NBTY Inc.	Vol #:	138

LET 15646	NBTY Inc.	Vol #:	138

LET 15647	Somalabs, Inc.	Vol #:	138

LET 15648	NBTY Inc.	Vol #:	138

LET 15649	NBTY Inc.	Vol #:	138

LET 15650	NBTY Inc.	Vol #:	138

LET 15651	NBTY Inc.	Vol #:	138

LET 15652	NBTY Inc.	Vol #:	138

LET 15653	NBTY Inc.	Vol #:	138

LET 15654	NBTY Inc.	Vol #:	138

LET 15655	NBTY Inc.	Vol #:	138

LET 15656	NBTY Inc.	Vol #:	138

LET 15657	NBTY Inc.	Vol #:	138

LET 15658	NBTY Inc.	Vol #:	138

LET 15659	NBTY Inc.	Vol #:	138

LET 15660	Meditrend, Inc,	Vol #:	138

LET 15661	Agro Labs, Inc.	Vol #:	138

LET 15662	Pharmanutrients, Inc.	Vol #:	138

LET 15663	Vita Pharmica, Inc.	Vol #:	138



LET 15664	Vita Pharmica, Inc.	Vol #:	138

LET 15665	Vita Pharmica, Inc.	Vol #:	138

LET 15666	Enzymatic Therapy	Vol #:	138

LET 15667	Enzymatic Therapy	Vol #:	138

LET 15668	Enzymatic Therapy	Vol #:	138

LET 15669	Enzymatic Therapy	Vol #:	138

LET 15670	Enzymatic Therapy	Vol #:	138

LET 15671	Enzymatic Therapy	Vol #:	138

LET 15672	Enzymatic Therapy	Vol #:	138

LET 15673	Enzymatic Therapy	Vol #:	138

LET 15674	Enzymatic therapy	Vol #:	138

LET 15675	Enzymatic Therapy	Vol #:	138

LET 15676	Enzymatic Therapy	Vol #:	138

LET 15677	McLind Corporation	Vol #:	138

LET 15678	McLind Corporation	Vol #:	138

LET 15679	McLind Corporation	Vol #:	138

LET 15680	McLind Corporation	Vol #:	138

LET 15681	McLind Corporation	Vol #:	138

LET 15682	McLind Corporation	Vol #:	138

LET 15683	McLind Corporation	Vol #:	138

LET 15684	McLind Corporation	Vol #:	138

LET 15685	McLind Corporation	Vol #:	138

LET 15686	McLind Corporation	Vol #:	138

LET 15687	McLind Corporation	Vol #:	138

LET 15688	McLind Corporation	Vol #:	138

LET 15689	McLind Corporation	Vol #:	138

LET 15690	McLind Corporation	Vol #:	138

LET 15691	McLind Corporation	Vol #:	138

LET 15692	Ortho Molecular Products, Inc.	Vol #:	138

2000N-1596	Uniform Compliance Date for Food Labeling Regulations

NFR 3	FDA	Vol #:	1

2003D-0167	Draft Guidance for Industry on Dispute Resolution Procedures for Science-based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability

N 1	FDA	Vol #:	1

2003D-0386	Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

N 2	FDA	Vol #:	1



2003P-0029	Remove metered-dose inhalers (MDI) containing moiety albuter

EMC 43	National Economic Research Associates Inc (NERA)	Vol #:	6

2004N-0181	Critical Path Initiative

C 63	Hoffmann-La Roche Inc	Vol #:	3

2004N-0527	Medical Devices; Medical Device Reporting

EMC 1	The Tamarack Group - Minneapolis, LLC	Vol #:	1

2004N-0535	Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request

C 6	Advanced Medical Technology Association (AdvaMed)	Vol #:	1

EMC 2	ZLB Behring	Vol #:	1

2004N-0559	Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents

EMC 24	Dong Bui MD	Vol #:	2

EMC 25	J Haught	Vol #:	2

EMC 26	S Caylor	Vol #:	2

EMC 27	A Doria	Vol #:	2

2004P-0113	immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur

LET 2	Public Citizen's Health Research Group	Vol #:	1

PDN 1	HFD-1 to Public Citizen	Vol #:	1

2004P-0329	Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes

EMC 1	R Thomsen	Vol #:	1

EMC 2	R Thomsen	Vol #:	1

2004P-0417	ANDA Doryx (coated doxycycline hyclate pellets) in powder or other fill present

LET 1	HFD-5 to Warner Chilcott	Vol #:	1

2005N-0083	Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics

N 1	FDA	Vol #:	1

2005P-0104	Determine whether Peptavlon (pentagastrin) was voluntarily withdrawn from sale for reasons other than safety or effectiveness

ACK 1	HFA-305 to Arnall Golden Gregory LLP	Vol #:	1

CP 1 Attachment A, B	Arnall Golden Gregory LLP	Vol #:	1

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FDA/Dockets Management