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.
The Investigational New Drug Application Process web page has an updated list of all guidances to help in the preparation of IND applications.
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.
The New Drug Application Process web page has an updated list of all guidances to help in the preparation of NDA applications.
The Abbreviated New Drug Application Process web page has an updated list of all guidances to help in the preparation of ANDA applications.