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Form FDA 1571 - U S Food and Drug Administration Home Page

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Form FDA 1571 - U S Food and Drug Administration Home Page

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 Application - Icahn School of ...

IND Application - [Date] page 1 [Sponsor-Investigator Name] This template was derived from FDA IND regulations (21CRF312.23), guidance for “Content and Format

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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INVESTIGATIONAL NEW DRUG (IND) APPLICATION

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

https://www.ouhsc.edu/IRB/IRB_Education/Program%20Materials/Programs%202012/Program_07/PP%20Handouts%20for%20Web/Clinical%20%20Research_GCP_v20110111_JGales_revised%20%5BCompatibility%20Mode%5D.pdf

Date added: October 24, 2013 - Views: 1

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CDER Regulatory Applications - Investigational New Drug and ...

Investigational New Drug and New Drug Applications REdI Conference June 19, ... Investigational New Drugs (INDs) New Drug Applications (NDAs) Drug Master Files (DMFs) ... Application content and organization (21 CFR 314.50) 1) ...

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM361332.pdf

Date added: September 8, 2013 - Views: 6

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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

https://www.ouhsc.edu/IRB/IRB_Education/Program%20Materials/Programs_2013/Program_07/PP%20Handouts%20for%20Web/Clinical_Research_GCP_v20120716.pdf

Date added: November 2, 2013 - Views: 1

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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DRAFT Guidance: Investigational New Drug Application An Investigational New Drug (IND) application is a request for Food and Drug Administration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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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.: DWD-POL-RA-001.02

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

Date added: May 12, 2012 - Views: 20

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Investigational New Drug Application and Approval Process

Irfan Siraj et al. / Investigational New Drug Application and Approval Process 1041 © 2010, IJPBA. All Rights Reserved. • Is not intended for humansubjects, but is

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

Date added: May 12, 2013 - Views: 2

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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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Subpart B—Investigational New Drug Application (IND)

55 Food and Drug Administration, HHS §312.22 (3) The applicant’s submission other-wise justifies a waiver. [52 FR 8831, Mar. 19, 1987, as amended at 52

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 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: 19

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

Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs FDA is amending its investigational new drug application (IND) regulation with two final rules:

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 1 [Sponsor-Investigator Name] This template presents the sections that comprise the IND application and was derived from FDA IND

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

Last revised 8-31-07 1 Content and Format of an Investigational New Drug (IND) Application I. General Information A. Phases of a Clinical Investigation

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

Date added: May 3, 2012 - Views: 10

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CMC Requirements for an Investigational New Drug Application ...

CMC Requirements for an Investigational New Drug Application (IND) Eldon E. Leutzinger, Ph.D. Office of New Drug Quality Assessment 1 CDER / FDA Two TopicImaging Workshop:

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

Date added: February 2, 2012 - Views: 23

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PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

64 §312.7 21 CFR Ch. I (4–1–98 Edition) statement ‘‘Caution: New Drug—Lim-ited by Federal (or United States) law to investigational use.’’

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 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 RESPONSIBLE FOR MONITORING THE CONDUCT AND PROGRESS OF THE CLINICAL

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

Date added: August 5, 2013 - Views: 1

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Investigational New Drug Application for TT-034 Submitted

Title: Investigational New Drug Application for TT-034 Submitted Author: Peter Frecnh Subject: IND for TT-034 Keywords: ddRNAi, TT-034, IND, Hepatitis C, Clinical Trial

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

Date added: January 20, 2014 - 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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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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Understanding FDA Regulatory Requirements for Investigational ...

ments necessary to conduct investigational drug studies. This review is intended to address the simplest scenario in which an ... INVESTIGATIONAL NEW DRUG APPLICATION There are different categories and types of IND. For individual sponsor-investigators, ...

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

Date added: March 17, 2012 - Views: 3

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Guidance for Industry - Weinberg Group

Investigational New Drug Applications ... 24 determining whether human research studies must be conducted under an investigational new 25 drug application (IND), ... 622 Human Research Without an Investigational New Drug Application, ...

http://www.weinberggroup.com/pdfs/Draft_Guidance_for_Industry_on_Investigational_New_Drug_Applications_(INDs)-Determining_Whether_Human_Research_Studies_Can_Be_Conducted_Without_an_IND.pdf

Date added: February 25, 2014 - 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://www.turner-white.com/pdf/hp_aug02_process.pdf

Date added: November 10, 2011 - Views: 8

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

and Phases 2/3 Investigational New Drug Applications Charles P. Hoiberg, Ph.D. Executive Director, ... Investigational New Drug Application (IND) What is an IND and how is it regulated? ... purity, and strength of the investigational drug, the amount of information needed will vary with the ...

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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Investigational New Drug (IND) Application Submission Checklist

Title: Investigational New Drug (IND) Application Submission Checklist Author: Laurie Kemble Created Date: 5/9/2012 9:16:15 AM

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) 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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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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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 use in the

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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VIA ELECTRONIC SUBMISSION RE: Docket No. FDA-2010-D-0503 ...

Human Research Studies Can Be Conducted Without an Investigational New Drug Application (Final Guidance). CRN is the leading trade association for the dietary supplement and ... investigational new drugs as a result of the Final Guidance, ...

http://www.crnusa.org/pdfs/CRN-Comments_IND-Final-Guidance-040714.pdf

Date added: July 2, 2014 - Views: 1

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FDA Accepts Chelsea Therapeutics' Investigational New Drug ...

FDA Accepts Chelsea Therapeutics' Investigational New Drug Application for Droxidopa Registration Trials to Begin in Fourth Quarter 2007 CHARLOTTE, N.C., Nov. 12, 2007 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the U.S. Food

http://chelseatherapeutics.com/wp-content/uploads/2014/01/CHTP_News_2007_11_12_News_Releases.pdf

Date added: April 16, 2014 - Views: 1

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IND Application Process: For The New Clinical Investigator

IND Application Process: For The New Clinical Investigator John M. Centanni Department of Medicine University of Wisconsin ... IND- Investigational New Drug IDE- Investigational Device Exemption. Applications Reviewed by FDA 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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INVESTIGATIONAL NEW DRUG APPLICATION (IND) NOTE: No drug may ...

form fda 1571 (3/05) previous edition is obsolete. page 1 of 2 department of health and human services food and drug administration investigational new drug application (ind)

http://pdsp.med.unc.edu/snidd/IND/Form%201571%20dLop.pdf

Date added: May 31, 2013 - Views: 2

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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 alters the FDA of its intentions to

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

Date added: July 23, 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 use in the

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

Date added: May 20, 2012 - Views: 1

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DRUG RESEARCH & DEVELOPMENT INVESTIGATIONAL NEW DRUG ...

INVESTIGATIONAL NEW DRUG APPLICATION (IND) Once adequate preclinical data have been obtained and there is reasonable justification to ... 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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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: 5

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Requirements for Investigational New Drug (IND) for Human ...

BWH Investigational Drug Service (IDS) and/or MGH Clinical Trials Pharmacy Committee. The . Policy: Requirements for IND for Human-Subjects Research Page 2 of 5 . ... Investigational New Drug (IND) Application to the FDA unless exemption 21 CFR

http://healthcare.partners.org/phsirb/Guidance/Requirements_for_an_IND_for_Human-Subjects_Research.1.11.pdf

Date added: February 21, 2012 - Views: 4

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Fiscal Year 2012 Investigational New Drug (IND) or ...

Fiscal Year 2012 Investigational New Drug (IND) or Investigational Device Exemption (IDE) Documentation Form . CDMRP Log Number:_____ Principal Investigator’s (PI’s) Name (please print):_____ Title of Application: ...

https://cdmrp.org/files/2012/prorp/cta_indide.pdf

Date added: October 24, 2013 - Views: 1

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Guidelines for Investigational New Drugs ( IND ) Requirements

1 September 2010 Page 2 of 49 Guidelines for Investigational New Drugs (IND) Requirements Version 1.1 Drug Sector

http://old.sfda.gov.sa/NR/rdonlyres/3E7516AA-BE71-467A-92CA-E8460FD69842/0/GuidelinesforInvestigationalNewDrug_IND__v11.pdf

Date added: June 1, 2013 - 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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INVESTIGATIONAL NEW DRUG APPLICATION (IND) NOTE: No drug may ...

12. CONTENTS OF APPLICATION This application contains the following items: (Check all that apply) 181 1. Fonn FDA 1571 (21 CFR 312.23(a)(l)]

http://www.maps.org/mdma/mp8_docs/fda_1571_12_18_09.pdf

Date added: February 3, 2012 - Views: 8

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New Drug Application (NDA) Process - MPS Society

New Drug Application (NDA) Process For decades, the regulation and control of new drugs in the United States has been based on the ... animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

http://www.mpssociety.org/wp-content/uploads/2011/05/New-Drug-Application-Process.pdf

Date added: April 1, 2012 - Views: 24

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7.0 Investigational Drugs and Devices in Research 7.1 ...

Investigational Drug Application or “IND”): refers to either an investigational new drug application or to a new drug that is used in clinical investigations. IND is synonymous with Notice of Claimed Investigational Exemption for a New Drug (FDA 21

http://www.pbrc.edu/hrpp/policies/documents/7.0-InvestigationalDrugs.pdf

Date added: August 6, 2013 - Views: 1

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INVESTIGATIONAL DEVICE and/or DRUG USAGE 1. PURPOSE: 2. POLICY

An investigational new drug application (IND) is synonymous with “Notice of Claimed Investigational Exemption for a New Drug.” An investigational drug must have an IND before it can be shipped, unless it falls under one of the categories of clinical

http://www.portland.va.gov/research/documents/hrpp/investigational-device.pdf

Date added: October 11, 2012 - Views: 3

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VHA HK 1108.04, Investigational Drugs and Supplies

the investigational drug or supply for a specific clinical investigation at the site. ... Is not covered under an Investigational New Drug (IND); or (4) ... Investigational New Drug (IND) Application.

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2497

Date added: October 13, 2012 - Views: 9

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INFORMATION FOR SPONSOR-INVESTIGATORS SUBMITTING ...

An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans. ... Where the investigational drug is obtained from a supplier in a final dosage

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

Date added: February 3, 2012 - Views: 5

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larifying the “New” in Investigational New Drug (IND)

Investigational Drug/Biologic – a new drug/biological drug that is used in a clinical investigation. This also includes a ... Investigational New Drug Application (IND) – a request for authorization from the FDA to administer an investigational

http://miamictsi.org/documents/CITI_IND_Primer_-_JW.pdf

Date added: March 21, 2014 - Views: 1

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The Evaluation of Impurities in Investigational New Drug and ...

Investigational New Drugs (INDs) – Initial INDs (Research/commercial) ... • Content and Format of Investigational New Drug Applications (INDs) ... – Incomplete application – Improper format (see 21 CFR § 314.50)

http://www.irvinepharma.com/pdf/finaltosend_Sarah_Pope.pdf

Date added: November 19, 2012 - Views: 2

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Investigational New Drug (IND) WORKBOOK - St. Luke's Hospital ...

Investigational New Drug (IND) WORKBOOK Institutional Review Board Department of Medical & Academic Affairs St. Luke's Hospital & Health Network

http://medaffairs.slhn.org/manny/irb/ind/ind-wkbk.pdf

Date added: February 3, 2012 - Views: 4

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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) - Scioderm announced that the US Food and Drug

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

Date added: October 24, 2013 - Views: 1