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 In this section:

                Development & Approval Process | Drugs

Development & Approval Process | Drugs

                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources Home
          Drugs
          Development & Approval Process | Drugs
          Guidance Documents for Drug ApplicationsDevelopment & Approval Process | Drugs Guidance Documents for Drug Applications
  
  	
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    PrintGuidance 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**

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

The New Drug Application Process web page has an updated list of all guidances to help in the preparation of NDA applications.**Guidance Documents for Abbreviated New Drug Applications**

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

                                                                                  Content current as of:
      12/10/2014
              
              
Regulated Product(s)
		 DrugsDevelopment & Approval Process | Drugs

          
                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources
 
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