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DN0663V5 CR22-02605 July 9,2002 Page 1 of18 (Nos - fda

DN0663V5 CR22-02605 July 9,2002 Page 1 of18 (Nos - fda

Request for Labeling of Genetically Engineered Foods - fda

Request for Labeling of Genetically Engineered Foods - fda

- r I 1 - fda

FDA OVERSIGHT HEARING ON CODEX BADLY NEEDED 7 wrmd - fda

FDA OVERSIGHT HEARING ON CODEX BADLY NEEDED 7 wrmd - fda

Science and Clinical Pharmacology - fda

Science and Clinical Pharmacology - fda

Enbrel (etanercept) for the Treatment of Pediatric Plaque Psoriasis

Enbrel (etanercept) for the Treatment of Pediatric Plaque Psoriasis

Science advisory board (sab) meeting - Food and Drug Administration - fda

Science advisory board (sab) meeting - Food and Drug Administration - fda

Radiesse for Soft Tissue Augmentation for the Treatment of Facial Lipoatrophy

Radiesse for Soft Tissue Augmentation for the Treatment of Facial Lipoatrophy

Metoclopramide: Drug Use Data Review - Food and Drug - fda

Metoclopramide: Drug Use Data Review - Food and Drug - fda

Excerpts from primary review of NDA 21-042 - Osteoarthritis

Excerpts from primary review of NDA 21-042 - Osteoarthritis

Briefing Document for the ODAC Single Patient Use of Investigational

Briefing Document for the ODAC Single Patient Use of Investigational

21-229 Jan, 2000 , May, 2000 - fda

21-229 Jan, 2000 , May, 2000 - fda

Llergen Declaration - fda

Llergen Declaration - fda

Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Suppl

Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Suppl

FOOD LABELING; DIETARY SUPPLEMENT NUTRITIONAL SUPPORT

FOOD LABELING; DIETARY SUPPLEMENT NUTRITIONAL SUPPORT

Ber 27, 1991 Proposed Rules - Food and Drug Administration - fda

Ber 27, 1991 Proposed Rules - Food and Drug Administration - fda

Finished course announement wisconsin doc doc - fda

Finished course announement wisconsin doc doc - fda

Finished course announement houston doc doc - fda

Finished course announement houston doc doc - fda

RH 104 Import Rad Health September 2012 Course Announcement doc

RH 104 Import Rad Health September 2012 Course Announcement doc

Low Acid Canned Food Inspections - Food and Drug Administration - fda

Low Acid Canned Food Inspections - Food and Drug Administration - fda

FD150151 Course announcement doc - fda

FD150151 Course announcement doc - fda

Critical Path Opportunities List

Critical Path Opportunities List

Attachment B - Validatin Form Example - fda

Attachment B - Validatin Form Example - fda

PEAK KILOVOLTAGE - fda

PEAK KILOVOLTAGE - fda

Food, Drug, and Cosmetic Act

Food, Drug, and Cosmetic Act

FOOD AND DRUG ADMINSITRATION FIELD MANAGEMENT

FOOD AND DRUG ADMINSITRATION FIELD MANAGEMENT

The Enforcement Story Fiscal Year 2006 Office of Criminal Investigations In Fiscal Year 2006, the ef

The Enforcement Story Fiscal Year 2006 Office of Criminal Investigations In Fiscal Year 2006, the ef

Appendix A RPM Change Request Form - fda

Appendix A RPM Change Request Form - fda

Questions and Answers from the November 19, 2009 FDA - fda

Questions and Answers from the November 19, 2009 FDA - fda

FDA Update on the H1N1 Flu Vaccine

FDA Update on the H1N1 Flu Vaccine

Appendix II Protocols and Report Forms

Appendix II Protocols and Report Forms

Medicines and You - Food and Drug Administration - fda

Medicines and You - Food and Drug Administration - fda

Prednisolone Sodium Phosphate Form Route - Food and Drug - fda

Prednisolone Sodium Phosphate Form Route - Food and Drug - fda

Contains Nonbinding Recommendations Guidance on Famotidine This guidance represents the Food and Dru

Contains Nonbinding Recommendations Guidance on Famotidine This guidance represents the Food and Dru

Renal function - Food and Drug Administration - fda

Renal function - Food and Drug Administration - fda

Nucynta ER REMS - Food and Drug Administration - fda

Nucynta ER REMS - Food and Drug Administration - fda

Frieden, MD, MPH

Frieden, MD, MPH

The purpose of this letter is to inform you that the Food and Drug Administration (FDA)

The purpose of this letter is to inform you that the Food and Drug Administration (FDA)

For injection, subcutaneous

For injection, subcutaneous

CDER Data Standards Manual Vocabulary Change Request Form - fda

CDER Data Standards Manual Vocabulary Change Request Form - fda

STN BL 125254 181

STN BL 125254 181

The vaccine, including egg protein, or following a previous dose of any

The vaccine, including egg protein, or following a previous dose of any

Understanding the Vaccine Adverse

Understanding the Vaccine Adverse

Drug Approvals

Form FDA-2359p NCIMS Aseptic Processing and Packaging Program Critical Listing Elements - fda

Form FDA-2359p NCIMS Aseptic Processing and Packaging Program Critical Listing Elements - fda

PERMISSION FOR PUBLICATION Publication Permission Section

PERMISSION FOR PUBLICATION Publication Permission Section

FDA 2359j Milk Sanitation Rating Report

FDA 2359j Milk Sanitation Rating Report

FDA 2359h Interstate Milk Shipper's check Rating Report

FDA 2359h Interstate Milk Shipper's check Rating Report

Setton Pistachio of Terra Bella, Inc Response to FDA Form 483, 5 - fda

Setton Pistachio of Terra Bella, Inc Response to FDA Form 483, 5 - fda

LAWRENCE, LISA D (ldl) - fda

LAWRENCE, LISA D (ldl) - fda

203388Orig1s000 - FDA - Food and Drug Administration

203388Orig1s000 - FDA - Food and Drug Administration

Evaluation of food effect on pharmacokinetics of vismodegib in

Evaluation of food effect on pharmacokinetics of vismodegib in

Risk Assessment and Risk Mitigation Review(s) - accessdata fda

Risk Assessment and Risk Mitigation Review(s) - accessdata fda

202276Orig1s000 - FDA - Food and Drug Administration

202276Orig1s000 - FDA - Food and Drug Administration

Center for Drug Evaluation and ResearchCDERFDA

Center for Drug Evaluation and ResearchCDERFDA

Transfer responsibility from Discovery to - accessdata fda

Transfer responsibility from Discovery to - accessdata fda

An epidemiologic study to compare the risk of severe hypersensitivity and

An epidemiologic study to compare the risk of severe hypersensitivity and

APPENDIX TO CLINICAL PHARMACOLOGY REVIEW - accessdata fda

APPENDIX TO CLINICAL PHARMACOLOGY REVIEW - accessdata fda

Proposed Proprietary - accessdata fda

Proposed Proprietary - accessdata fda

OTHER REVIEW(S) - FDA - Food and Drug Administration - accessdata fda

OTHER REVIEW(S) - FDA - Food and Drug Administration - accessdata fda

CLINICAL REVIEW OF SAFETY LABELINGREMS SUPPLEMENT - accessdata fda

CLINICAL REVIEW OF SAFETY LABELINGREMS SUPPLEMENT - accessdata fda

Type of submission

Type of submission

Risk Assessment and Risk Mitigation Review(s) - gov fda - accessdata fda

Risk Assessment and Risk Mitigation Review(s) - gov fda - accessdata fda

PHARMACOLOGY REVIEW(S)

PHARMACOLOGY REVIEW(S)

PHARMACOLOGY REVIEW(S) - gov fda accessdata www - accessdata fda

PHARMACOLOGY REVIEW(S) - gov fda accessdata www - accessdata fda

Administrative Document(s) and Correspondence - accessdata - accessdata fda

Administrative Document(s) and Correspondence - accessdata - accessdata fda

21-318 S-016 - accessdata fda

21-318 S-016 - accessdata fda

ZOCOR (simvastatin) Tablets - gov fda accessdata www

ZOCOR (simvastatin) Tablets - gov fda accessdata www

COUMADIN TABLETS

COUMADIN TABLETS

IMPLANON (etonogestrel implant) 68 mg For Subdermal Use Only - accessdata fda

IMPLANON (etonogestrel implant) 68 mg For Subdermal Use Only - accessdata fda

FORTEO NDA: 21-318 S-012

FORTEO NDA: 21-318 S-012

LOTRISONE Cream

LOTRISONE Cream

(morphine sulfate extended-release) Capsules

(morphine sulfate extended-release) Capsules

CAUSES BIRTH DEFECTS DO NOT GET PREGNANT - accessdata fda

CAUSES BIRTH DEFECTS DO NOT GET PREGNANT - accessdata fda

(Warfarin Sodium Tablets, USP) Crystalline

(Warfarin Sodium Tablets, USP) Crystalline

Duragesic Label

Duragesic Label

Orally Disintegrating Tablets

Orally Disintegrating Tablets

Approval Letter - FDA - Food and Drug Administration

Approval Letter - FDA - Food and Drug Administration

Surgical Sealant - accessdata fda

Surgical Sealant - accessdata fda

Summit Glove Inc

Summit Glove Inc

NIC SEC FilingsNIC - NIC Inc

NIC SEC FilingsNIC - NIC Inc

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) - accessdata fda

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) - accessdata fda

Pre-market Notification -510(k)

Pre-market Notification -510(k)

Vessel Sealing System

Vessel Sealing System

Peregrine Surgical Ltd - accessdata fda

Peregrine Surgical Ltd - accessdata fda

K II- 2 - accessdata fda

K II- 2 - accessdata fda

APR 172012 - accessdata fda

APR 172012 - accessdata fda

TOP CALIBRE SDN - accessdata fda

TOP CALIBRE SDN - accessdata fda

510(k) Summary 82012 8 21 CFR 807 - accessdata fda

510(k) Summary 82012 8 21 CFR 807 - accessdata fda

GE H-ealthcare

510(k) SUMMARYMA - accessdata fda

510(k) SUMMARYMA - accessdata fda

ZO B A KIo - z - accessdata fda

ZO B A KIo - z - accessdata fda

Section IV 510k Summary

Section IV 510k Summary

Cat b'3Ful'

510(K) Summary OCT 2 1 2010 - gov fda accessdata www

510(K) Summary OCT 2 1 2010 - gov fda accessdata www

APR 1 4 K11

'Exact Medical Manufacturing, - accessdata fda

'Exact Medical Manufacturing, - accessdata fda

"This summary of5lO(k) safety and effectiveness information is being submitted in accordance

"This summary of5lO(k) safety and effectiveness information is being submitted in accordance

Summary SEP 217 2010

Summary SEP 217 2010

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