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Drug Applications |
U.S. Food and Drug Administration • Center for Drug Evaluation and Research |
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Drug Applications |
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Guidance Documents for Drug ApplicationsGuidance 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. Most of these
documents are in Adobe Acrobat
format Guidance Documents for Investigational New Drugs
Guidance Document for Emergency INDs
Guidance Documents for New Drug Applications
Guidance Documents for Abbreviated New Drug Applications
FDA/Center for Drug Evaluation and Research |
, also know as PDF. The 
