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Investigational New Drug Applications (INDs) — Determining ...

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Investigational New Drug Applications (INDs) — Determining ...

subjects must be conducted under an investigational new drug application ... This guidance does not address expanded access to investigational drugs for treatment use ...

http://www.fda.gov/downloads/Drugs/Guidances/UCM229175.pdf

Date added: October 24, 2013 - Views: 1

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FDA Form 1571 - Cover Letter to FDA - U S Food and Drug ...

Next Page . Export Data . Import Data . Reset Form . DEPARTMENT OF HEALTH AND HUMAN SERVICES . Food and Drug Administration . INVESTIGATIONAL NEW DRUG APPLICATION (IND)

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf

Date added: November 10, 2011 - Views: 48

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INVESTIGATIONAL NEW DRUG (IND) APPLICATION

3 IRB New Study Application IND Exemption Criteria [21CFR312(b)] No new indication or other significant labeling change Lawfully marketed; not in support of a significant

http://www.ouhsc.edu/IRB/IRB_Education/Program%20Materials/Programs_2014/2014_April/PP%20Handouts%20for%20Web/Clinical_Research_GCP_v20140106.pdf

Date added: May 6, 2014 - Views: 1

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NEWS RELEASE -IND MEETING REQUEST

Biohaven filed a pre-IND meeting request with the FDA regarding lead investigational ... planned filing of an investigational new drug application ...

http://www.cnsx.ca/cmsAssets/docs/Filings/2014/2014_12_18_14_02_25_PBT.U_Bihaven_update.pdf

Date added: December 21, 2014 - Views: 1

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Investigational New Drug Application - Icahn School of ...

Mount Sinai School of Medicine Investigational New Drug Application Regulatory Sponsor: Insert the Name of the Sponsor-Investigator Insert Department Name

http://icahn.mssm.edu/static_files/MSSM/Files/Research/Programs/Office%20of%20Clinical%20Research/IND_ApplicationTemplate.pdf

Date added: February 25, 2013 - Views: 8

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Guidance: Investigational New Drug Application

DRAFT Guidance: Investigational New Drug Application An Investigational New Drug (IND) application is a request for Food and Drug Administration

http://academics.ochsner.org/uploadedFiles/Research/Redesign/Clinical_Research/Human_Subjects_Research__Protection_Program/Guidance_InvestigationalNewDrugApplication.pdf

Date added: November 29, 2013 - Views: 1

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The Investigational New Drug (IND) and New Drug Application ...

The Investigational New Drug (IND) and New Drug Application (NDA) Process Susan Honig, MD Division of Oncology Drug Products. US Food & Drug Administration

http://ocw.jhsph.edu/courses/drugdevelopment/PDFs/IND-NDA%20Lecture.pdf

Date added: March 8, 2012 - Views: 21

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INVESTIGATIONAL NEW DRUG APPLICATION (IND)

form fda 1571 (4/06) previous edition is obsolete. page 1 of 2 department of health and human services food and drug administration investigational new drug ...

http://www.rfspharma.com/images/IND_57159_SN_098_submission_04252011.pdf

Date added: December 21, 2014 - Views: 1

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Cleveland Clinic Research Glossary of Terms

The investigational new drug (IND) application permits a ... Clinical Research IND/IDE Office prior to submitting an IND application. Investigational Device ...

http://my.clevelandclinic.org/florida/ccf/media/Files/Florida/clinical_research/Glossary121209.pdf

Date added: December 21, 2014 - Views: 1

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INITIAL INVESTIGATIONAL NEW DRUG APPLICATION

INITIAL INVESTIGATIONAL NEW DRUG APPLICATION IND Title (if title being used) Serial 0000 Name of Sponsor Investigator, MD X Professor, Department

http://med.dartmouth-hitchcock.org/documents/CTO_IND_application.pdf

Date added: August 28, 2013 - Views: 1

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Investigational New Drug Application and Approval Process

The investigational new drug (IND) application is the result of a successful preclinical development program. ... investigational drug for filing the IND/NDA.

http://www.ijpba.info/ijpba/index.php/ijpba/article/download/334/228

Date added: May 12, 2013 - Views: 2

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PART 312— INVESTIGATIONAL NEW DRUG APPLICATION

61 Food and Drug Administration, HHS Pt. 312 is required for marketing. In the ab-sence of an approved new drug applica-tion or abbreviated new drug applica-

http://www.gpo.gov/fdsys/pkg/CFR-1998-title21-vol5/pdf/CFR-1998-title21-vol5-part312.pdf

Date added: September 7, 2013 - Views: 1

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Investigational New Drug Applications: two cases

New IND Application: Fish Oil to reduce fatty liver in obese adolescents • New condition: NAFLD in adolescents • Dosage: 4g/d (FDA approved in adults

http://www.bumc.bu.edu/irb/files/2009/05/CLenders%20-%20IND%20cases%204-2009.pdf

Date added: May 6, 2013 - Views: 1

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INVESTIGATIONAL NEW DRUG APPLICATION (IND)

RFS Pharma, LLC Confidential _____ Amdoxovir Annual Report, IND 57,159 4 1/25/2011

http://www.rfspharma.com/images/57159_annual_report_serial_97_Jan_25_2011.pdf

Date added: December 21, 2014 - Views: 1

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Investigational New Drug Applications: two cases

Conclusions • Before you start a IND application, try to identify a PI who previously submitted an IND application • Identify the division at the FDA that best ...

http://www.bumc.bu.edu/crro/files/2010/01/Lenders-4-14-09.pdf

Date added: May 6, 2013 - Views: 1

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Investigational New Drug (IND) Application > Final Rules for ...

FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs 6 FDA News Release (8/12/2009) Proposed Rules: Charging for Investigational Drugs and ...

http://ycci.yale.edu/comply/426_84865_1InvestigationalDrugs.pdf

Date added: February 25, 2014 - Views: 1

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Investigational New Drug Application - Icahn School of ...

IND Application - [Date] page iii [Sponsor-Investigator Name] Table of Contents [Double-check that this table matches the contents of the document]

http://icahn.mssm.edu/static_files/MSSM/Files/Research/Resources/Office%20of%20Clinical%20Research/2013%20PDFs/6_IND_Application.pdf

Date added: September 8, 2013 - Views: 1

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Investigational Drug Products

Withdrawal of IND Application for an Investigational Drug: IND Withdrawal Guidance and Template for ... INVESTIGATIONAL NEW DRUG APPLICATION

http://ictr.johnshopkins.edu/wp-content/uploads/2014/02/Withdrawal-of-IND-Application-for-Drugs-Products.pdf

Date added: December 21, 2014 - Views: 1

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IND Application for an Investigational Biologic

IND Application for an Investigational Biologic: ... IND Investigational New Drug CFR Code of Federal Regulations FDA U.S. Food and Drug Administration

http://ictr.johnshopkins.edu/wp-content/uploads/import//1466-IND%20Application%20Guidance%20and%20Template_Biologic_Somatic%20Cell%20Therapy.pdf

Date added: July 5, 2013 - Views: 1

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Subpart B—Investigational New Drug Application (IND)

56 §312.23 21 CFR Ch. I (4–1–11 Edition) (b) The amount of information on a particular drug that must be submitted in an IND to assure the accomplish-

http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol5/pdf/CFR-2011-title21-vol5-sec312-22.pdf

Date added: September 8, 2013 - Views: 1

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The Drug Development Process II: Investigational New Drug ...

he development of a new drug requires strict adherence to the Code of Federal Regulations, starting with the application for study of the compound in human subjects.

http://mobile.turner-white.com/pdf/hp_aug02_process.pdf

Date added: December 21, 2014 - Views: 1

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Investigational New Drug Application

Navigating Through Regulatory Waters: The DOs and DON’Ts of Preparing an Investigational New Drug Application Larissa Lapteva, M.D., M.H.S OND/CDER/FDA

http://c.ymcdn.com/sites/www.actscience.org/resource/resmgr/navigating_the_fda_landscape.pdf

Date added: September 28, 2014 - Views: 1

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Investigational New Drug Applications: Sponsor and ...

Investigational New Drug ... investigational drug, ... investigational drug to the Sponsor of the IND application, or otherwise

http://www.research.vcu.edu/IND_IDE/IND_sponsor_investigator_responsibilities.pdf

Date added: August 22, 2014 - Views: 1

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Policy: Determination of Investigational New Drug Application ...

DAIDS Bethesda, MD USA POLICY Determination of Investigational New Drug Application (IND) Approval Date: 20 DEC 06 No ...

http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/archiveddeterminationind.pdf

Date added: May 12, 2012 - Views: 20

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CMC Requirements for an Investigational New Drug Application ...

Outline of Presentation • General Requirements for CMC • IND Resources 2 • Application to PET Drugs • CMC in Multi-Center IND Clinical Trials

http://www2.rsna.org/re/TwoTopicImagingWorkshopPresentations/Index%20Files/Leutzinger.pdf

Date added: February 2, 2012 - Views: 27

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Investigational New Drug (IND) or Investigational Device ...

Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application Status Form I hereby certify that, for the proposed study

https://cdmrp.org/files/2011/prmrp/cta_indide.pdf

Date added: January 11, 2013 - Views: 2

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Guidance on CMC for Phase 1 and Phases 2/3 Investigational ...

Investigational New Drug Application (IND) ... – “CGMP for Phase 1 Investigational Drugs” (2008) Drug Information Association www.diahome.org 11.

http://www.diahome.org/productfiles/25849/20110518/track4/11%20t4-4_chuck%20hoiberg.pdf

Date added: November 11, 2012 - Views: 4

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Content and Format of an Investigational New Drug (IND ...

Last revised 8-31-07 4 The IND content and format set forth below should be followed by the sponsor in the interest of fostering an efficient FDA review of the

http://hsc.unm.edu/research/ctsc/Docs/ContentandFormatofINDApplication.pdf

Date added: May 3, 2012 - Views: 12

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INVESTIGATIONAL NEW DRUG APPLICATION (IND) NOTE: No drug may ...

12. FORM FDA 1571 (1/03) CONTENTS OF APPLICATION This application contains the following items: (Check all that apply) PAGE 2 OF 2 14. NAME AND TITLE OF THE PERSON ...

http://www.venomousreptiles.org/libraries/download/2445/FDA-1571.pdf

Date added: August 5, 2013 - Views: 1

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Investigational New Drug (IND) Application > Physician ...

Title: Investigational New Drug (IND) Application > Physician Request for an Individual Patient IND under Expanded Access for Non-emer Author: aef24

http://ycci.yale.edu/comply/426_84869_4physicianrequest.pdf

Date added: May 6, 2013 - Views: 2

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Required Reports to a FDA-Accepted Investigational New Drug ...

June 17, 2014 1 Required Amendments and Reports to a FDA-Accepted Investigational New Drug (IND) Application . I. Protocol Amendments1. Once an IND application has ...

http://www.research.vcu.edu/IND_IDE/IND_required_amendments_and_reports.pdf

Date added: August 22, 2014 - Views: 1

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DRUG RESEARCH & DEVELOPMENT INVESTIGATIONAL NEW DRUG ...

INVESTIGATIONAL NEW DRUG APPLICATION (IND) ... The investigational review board is an independent body with no member having a vested interest in the trial.

http://r-research.com/forms/DrugResearchDevelopment.pdf

Date added: October 24, 2013 - Views: 1

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Is an Investigational New Drug (IND) Application Required?

Is an Investigational New Drug (IND) Application Required? Will a drug be used, administered, applied, or ... procedure, it is exempt from IND requirements as

http://medicine.umich.edu/medschool/sites/medicine.umich.edu.medschool/files/res_irbmed_Is%20an%20IND%20Required.pdf

Date added: November 29, 2013 - Views: 1

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Understanding FDA Regulatory Requirements for Investigational ...

may require filing an Investigational New Drug (IND) application with the FDA. ... ments necessary to conduct investigational drug studies. This

http://www.ucdmc.ucdavis.edu/clinicaltrials/IND/ind_documents/JournalofInvestigativeMedicineAugust2009.pdf

Date added: March 17, 2012 - Views: 3

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Investigational New Drug Application for TT-034 Submitted

ASX ANNOUNCEMENT Investigational New Drug application for TT-034 submitted Sydney, Australia, 9 December 2013: RNAi-based therapeutics company Benitec

http://www.benitec.com/documents/131209_IND_Lodgement.pdf

Date added: January 20, 2014 - Views: 1

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INVESTIGATIONAL NEW DRUG APPLICATION (IND) NOTE: No drug may ...

FORM FDA 1571 (3/05) PREVIOUS EDITION IS OBSOLETE. PAGE 2 OF 2 12. CONTENTS OF APPLICATION This application contains the following items: (Check all that apply)

http://pdsp.med.unc.edu/snidd/IND/Form%201571%20MeS-IMPY.pdf

Date added: September 7, 2013 - Views: 1

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INFORMATION FOR SPONSOR-INVESTIGATORS SUBMITTING ...

INFORMATION FOR SPONSOR-INVESTIGATORS SUBMITTING INVESTIGATIONAL NEW DRUG APPLICATIONS (INDs) An Investigational New Drug Application (IND) is a request for Food and Drug

http://www.venomousreptiles.org/libraries/download/2450/1571-1572-help.pdf

Date added: February 3, 2012 - Views: 5

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[Revised as of April 1, 2004] Title 21 Food and Drugs ...

Part 312 Investigational New Drug Application ... sponsor, is responsible for the control and distribution of the investigational drug, and the IND

http://www.nj.gov/health/irb/documents/21_cfr_312.pdf

Date added: November 29, 2013 - Views: 1

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Investigational New Drug Application Readiness FDA Resources

Investigational New Drug Application Readiness FDA Resources Angioma(Alliance(10th(Anniversary(CCM(Scienti7ic(Meeting((November6,2014 (KathrynO’Connell,MDPhD

http://www.angiomaalliance.org/documents/FDA%20Powerpoint.pdf

Date added: December 21, 2014 - Views: 1

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IND Application Process: For The New Clinical Investigator

IND Application Process: For The New Clinical Investigator ... IND- Investigational New Drug IDE- Investigational Device Exemption. Applications Reviewed by FDA

https://secure.emmes.com/pactweb/system/files/wb_workshop_centanni.pdf

Date added: January 20, 2014 - Views: 1

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Is an Investigational New Drug (IND) Application Required?

Is an Investigational New Drug (IND) Application Required? Will a drug be used, administered, applied, or implanted to subjects?? A product that is (i) intended for ...

http://www.hrpp.umich.edu/policies/IND.pdf

Date added: May 20, 2012 - Views: 1

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Investigational New Drug (IND) Application Submission Checklist

Investigational New Drug (IND) Application Submission Checklist ... General Investigational Plan: Brief description of the overall plan for investigating the drug

http://researchcompliance.uc.edu/Libraries/Human_Subjects_Research_PAM_Documents/IND-_Fling_Chklist_2.sflb.ashx

Date added: May 31, 2013 - Views: 2

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Investigational New Drug (IND) Outreach Responsibilities of ...

Responsibilities of IND Sponsor-Investigators AGENDA 1. INVESTIGATIONAL NEW DRUG (IND) APPLICATION PROCESS WHATISANIND?WHAT IS AN IND? APPLICABLE REGULATIONS

http://www.michr.umich.edu/Uploads/Research%20Management/Regulatory%20Support/Investigator%20outreach%20presentation%209NOV10%20final.pdf

Date added: October 5, 2012 - Views: 6

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Investigational New Drug (IND) Applications and NMDP Update

Investigational New Drug (IND) ... •an approved biological license application ... •Investigational New Drug Applications ...

http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/uploads/files/Resources/Annual%20Meeting/2010%20Annual%20Meeting/Mon%200730.2%20Phillips-Johnson%20Philli%20S.pdf

Date added: April 16, 2014 - Views: 2

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Is an Investigational New Drug (IND) Application Needed ...

Is an Investigational New Drug (IND) Application Needed? Bioavailability or Bioequivalence Studies Does the drug: - contain a “new chemical entity” or

http://hrpp.umich.edu/policies/bioavailability.pdf

Date added: November 10, 2011 - Views: 7

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Reporting Requirements for Sponsor-Investigators Conducting ...

Conducting Investigational New Drug (IND) or Investigational Device ... investigators of their reporting obligations to ... Investigational New Drug Application

http://www.mayo.edu/research/documents/38-reporting-req-for-sponsor-investigational-devicepdf/DOC-10027871

Date added: September 7, 2013 - Views: 1

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Scioderm’s Investigational New Drug (IND) Application for ...

Scioderm’s Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA Raleigh, N.C. (February 1, 2013) - ...

http://www.sderm.com/wp-content/uploads/2013/02/final-feb-2013-Scioderm-Press-Release.pdf

Date added: October 24, 2013 - Views: 1

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IND FAQ What is an IND? What is the purpose of an IND?

IND FAQ. What is an IND? The Investigational New Drug (IND) application fulfills two regulatory requirements. First, the application is through which a drug sponsor ...

http://www.childrenshospital.org/~/media/Research%20and%20Innovation/Research%20Search/INDFAQ%20Drug.ashx

Date added: July 23, 2014 - Views: 1

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The Sponsor's Guide to Regulatory Submissions for an ...

Sponsor’s Guide to Regulatory Submissions for an Investigational New Drug Chapter 1. Introduction Chapter 1 I. Introduction An Investigational New Drug Application ...

http://www.botanicalmedicine.org/FDA%20Submissions_NCI_IND.pdf

Date added: August 18, 2013 - Views: 2