Newly Added FDA Guidance Documents
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

 Search for FDA Guidance Documents
 http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

  Investigational New Drug (IND) Application
  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplic  ations/InvestigationalNewDrugINDApplication/default.htm

 New Drug Application - Resources for NDA Submissions

​ http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplicatio ns/newdrugapplicationnda/default.htm

  Applications Covered by Section 505(b)(2)

  http://www.fda.gov/downloads/Drugs/Guidances/ucm079345.pdf

​​  FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND; Frequently Asked    Questions

  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

  Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review

  http://www.fda.gov/ForPatients/Approvals/Fast/default.htm

  Formal Meetings Between the FDA and Sponsors or Applicants
  http://www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf

  Labeling for Human Prescription Drug and Biological Products

  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075082.pdf

 Guidance for IRBs, Clinical Investigators and Sponsors
 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM328855.pdf

  New Drug Application (NDA)
  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplic ations/NewDrugApplicationNDA/default.htm

 Expedited Programs for Serious Conditions – Drugs and Biologics
 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
 
 Target Product Profile — A Strategic Development Process Tool
 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf

 INTEGRATED ADDENDUM - ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE
 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2. pdf

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