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Guidances: Annotated Listing for Rare Diseases

Guidances

Guidance documents (Guidances) represent FDA’s current thinking on a particular subject.  Guidances do not establish legally enforceable responsibilities, and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  There are many Guidances on FDA’s website pertaining to a wide variety of topics.  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Selected Guidance Documents

Formal Meetings Between the FDA and Sponsors or Applicants
Recommended principles and practices to be followed to request formal meetings with CDER OND review divisions, and meeting practices for these meetings (such as preparing for and conducting meetings) are discussed in this Guidance.  Formal meetings include face-to-face meetings, teleconferences, and videoconferences.  

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs 
Clarifies requirements for data and data presentation in initial IND submissions. 
 

Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products 
This guidance is intended to provide guidance to sponsors planning to file NDAs, BLAs or supplemental applications to demonstrate effectiveness.
 

E10 Choice of Control Group and Related Issues in Clinical Trials 
This guidance is intended to assist sponsors in choosing a trial design and control group for clinical trials in order to demonstrate the efficacy of a treatment.
 

E9 Statistical Principles for Clinical Trials
This guidance is intended to give direction to sponsors in the design, conduct, analysis, and evaluation of clinical trials of an investigational product in clinical development.
 

Fast Track Drug Development Programs-Designation, Development, and Application Review
This document provides guidance to sponsors on the regulations, policies, and procedures related to FDA's fast track programs and clarifies the criteria and processes for designating fast track products.
 

Special Protocol Assessment
This document is intended to provide guidance to sponsors on procedures adopted by CDER and CBER for evaluating issues related to adequacy of proposed studies associated with the development of products in human drug applications.
 

Qualification Process for Drug Development Tools
This guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs.