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DOCKETS MANAGEMENT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Dockets Entered On June 17, 2003

TABLE OF CONTENTS (Linked)

 

 

 

Docket #

 

Title

 

 

 

 

 

 

2003D-0228

 

Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA

 

 

 

2003P-0274

 

In re Tier 1 initial Approval Program

 

 

 

2003P-0275

 

Reclassify Cyclosporine (CSA) as Non-antibiotic Drug

 

 

 

2003P-0276

 

Establish Interim Accetable Levels for Acrylamide In Major Food Sources

 

 

 

2003P-0277

 

Indicate to Potential Users of a Drug by Means of Labelling Whether Any Product Had Used Human Embryo or Material Derived From Human Embryos in Its Development, Production or Testing

 

CONTENTS

 

1977N-0094A

 

Internal analgesic, antipyretic & antirheumatic drug

 

 

 

 

 

BKG 2

 

Background Information

 

Vol #:

 

1

 

 

 

2002H-0443

 

Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

 

 

 

 

 

CS 11

 

HFA-305

 

Vol #:

 

1

 

 

 

MO 8

 

LaHaye Ceter for Advanced Eye Care of Lafayette, D/B/A LaHaye Total Eye Care

 

Vol #:

 

1

 

 

 

MO 9

 

LaHaye Center for Advanced Eye Care of Lafayette, D/B/A LaHaye Total Eye Care

 

Vol #:

 

1

 

 

 

OR 9

 

HF-3

 

Vol #:

 

1

 

 

 

2003D-0228

 

Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA

 

 

 

 

 

GDL 1

 

Guidance

 

Vol #:

 

1

 

 

 

2003N-0193

 

Ophthalmic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment

 

 

 

 

 

BKG 1

 

Background Information

 

Vol #:

 

1

 

 

 

2003P-0274

 

In re Tier 1 initial Approval Program

 

 

 

 

 

ACK 1

 

HFA to Abigail Alliance and the Washington Legal Foundation

 

Vol #:

 

1

 

 

 

CP 1

 

Abigail Alliance and the Washington Legal Foundation

 

Vol #:

 

1

 

 

 

2003P-0275

 

Reclassify Cyclosporine (CSA) as Non-antibiotic Drug

 

 

 

 

 

ACK 1

 

HFA-305

 

Vol #:

 

1

 

 

 

CP 1

 

Allergan Inc.

 

Vol #:

 

1

 

 

 

2003P-0276

 

Establish Interim Accetable Levels for Acrylamide In Major Food Sources

 

 

 

 

 

ACK 1

 

HFA-305

 

Vol #:

 

1

 

 

 

CP 1

 

CSPI

 

Vol #:

 

1

 

 

 

2003P-0277

 

Indicate to Potential Users of a Drug by Means of Labelling Whether Any Product Had Used Human Embryo or Material Derived From Human Embryos in Its Development, Production or Testing

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACK 1

 

HFA-305

 

Vol #:

 

1

 

 

 

CP 1

 

Arthur Young

 

Vol #:

 

1

 

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