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U.S. Food and Drug Administration Center for Drug Evaluation and Research

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Drug Applications

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New Drug Application (NDA) Process

Introduction

For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization.  The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

  • Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
  • Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
  • Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.  The following resources provide summaries on NDA content, format, and classification, plus the NDA review process:

  • For a brief history of U.S. drug law, please see Benefit vs. Risk: How CDER Approves New Drugs.
  • The New Drug Development section of the CDER Handbook provides an understanding of how CDER works to assure that safe and effective drugs are available to the American people.
  • New Drug Application (NDA) Review Process Chart provides a general overview of CDER's new drug application review process, including how CDER determines the benefit:risk profile of a drug product prior to approval for marketing.
  • Review Diagram Project  provides links to several flowcharts from CDER review divisions that show the framework, content, process and issues involved in review activity. The diagrams represent attempts by individual medical officers to visualize their own review processes; they do not represent official CDER or division standards.

This web site is designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations, or their organizations interested in bringing new drugs to market. Each of the sections below contains information from CDER to assist you in the NDA application process.  For specific information, click on a link to go directly to a section or webpage.

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Resources for NDA Submissions

The following resources have been gathered to provide you with the legal requirements of a new drug application, assistance from CDER to help you meet those requirements, and internal NDA review principles, policies and procedures.

Guidance Documents for NDAs

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 information on a specific guidance document, please contact the originating office.

For the complete list of CDER guidances, please see the Guidance Index.  Most of these documents are in Adobe Acrobat format Adobe Acrobat Symbol, also know as PDF.   The free upgrade to Adobe Acrobat 3.0 or higher is recommended, especially if you have difficulty opening any of the documents below.  For information on a specific guidance document, please contact the originating office.

Guidance documents to help prepare NDAs include:

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Laws, Regulations, Policies and Procedures

The mission of  FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook.  The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world.  The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.

Code of Federal Regulations (CFR)

Code Of Federal Regulations (CFR)   The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR.  The CFR is divided into 50 titles which represent broad areas subject to Federal regulations.  The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act and related statutes.  Section 21 of the CFR contains all regulations pertaining to food and drugs.  The regulations document all actions of all drug sponsors that are required under Federal law. 

  • 21CFR Part 314 - Applications for FDA Approval to Market a New Drug or an Antibiotic Drug.

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MaPPs

CDER's Manual of Policies and Procedures (MaPPs). These documents are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. MaPPs define external activities as well. All MaPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures. MaPPS of particular interest to NDA applicants include:

  • 4170.11 DIDP Procedures for Processing NDA and NDA Supplement Approval Letters and Action Packages to Be Posted on the Internet (Issued 7/8/2003)
  • 5015-6 Review of the Same Supplemental Change to More than One NDA or ANDA in More Than One Review Division (Issued 1/14/2000, Posted 1/19/2000)
  • 6010.5 NDAs: Filing Review Issues (Issued 5/8/2003, Posted 5/14/2003)
  • 6020.8 Action Packages for NDAs and Efficacy Supplements (Issued 11/13/2002, Posted 12/11/2002)
  • 6050.1. PDF document Refusal to Accept Application for Filing From Applicants in Arrears
  • 7211.1PDF document Drug Application Approval 501(b) Policy
  • 7600.6. PDF document Requesting and Accepting Non-Archivable Electronic Records for New Drug Applications.

Prescription Drug User Fee Act (PDUFA)

On November 21, 1997, The President signed the Food and Drug Administration Modernization Act of 1997.  This legislation includes authorization for FDA to continue to collect three types of user fees from applicants who submit certain new drug and biological product applications.  FDA was first authorized to collect user fees under the Prescription Drug User Fee Act (PDUFA) of 1992.

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NDA Forms and Electronic Submissions

Advisory Committees

Advisory committees provide independent advice and recommendations to the FDA on scientific and technical matters related to the development and evaluation of products regulated by the Agency.  CDER requests advice from advisory committees on a variety of matters, including various aspects of clinical investigations and applications for marketing approval of drug products.  Committee members are scientific experts such as physician-researchers and statisticians, as well as representatives of the public, including patients.  Although the committees provide recommendations to the Agency, final decisions are made by FDA.

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Targeted Product Information (TPI) Project

After a 12-month collaborative effort between FDA and the Pharmaceutical Research Manufacturers Association (PhRMA), FDA’s Office of Drug Evaluation IV (ODE IV) started a pilot test of a tool that may improve the drug development process.   This tool is the Targeted Product Information (TPI) Document.  The sponsor writes the TPI to guide the design, conduct, and analysis of clinical trials so that at the end of the development program, the sponsor will have gathered the necessary data to support the desired outcome, the approval and appropriate labeling, or package insert, of the drug under development.

  • TPI Program Overview.   Includes background information, intent of the TPI document, what the TPI document is and is not, plus a summary.
  • TPI Template.  The template provides a recommended outline for a TPI with a description of suggested information for each section.

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Related Topics

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Last Updated: December 30, 2003
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