Guidance Documents for Drug Applications

Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.   They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures.  Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts.  An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

For the complete list of CDER guidances, please see the Guidance Index.  

Guidance Documents for Investigational New Drugs

 Guidance Document for Emergency INDs

  • The Guidance for Institutional Review Boards and Clinical Investigators contains information on: Obtaining an Emergency IND, Emergency Exemption from Prospective IRB, Approval Exception From Informed Consent, and Requirement Planned Emergency Research, Informed Consent Exception.

Guidance Documents for New Drug Applications 

Guidance Documents for Abbreviated New Drug Applications 


More in Development & Approval Process (Drugs)

Clinical Data Summary Pilot Program Drug Development Tool Qualification Programs Guidance Documents for Drug Applications Laws, Regulations, Policies and Procedures for Drug Applications

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