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Investigational New Drug (IND) Application ProcessIntroductionCurrent Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA. During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies. FDA's role in the development of a new drug begins when the drug's sponsor (usually the manufacturer or potential marketer) having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans. At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system. There are three IND types:
There are two IND categories:
The IND application must contain information in three broad areas:
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk. This interactive chart summarizes the IND process, including how CDER determines if the product is suitable for use in clinical trials. This web site is designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations, or other organizations interested in bringing a new drug to market. Each of the sections below contains information from CDER to assist you in the IND application process. For specific information, click on a link to go directly to a section or webpage. Resources for IND ApplicationsThe following resources have been gathered to provide you with the legal requirements of an IND application, assistance from CDER to help you meet those requirements, and internal IND review principles, policies and procedures.
Pre-IND
Consultation Program: CDER offers a Pre-Investigational New Drug
Application (IND) Consultation Program to foster early communications
between sponsors and new drug review divisions in order to provide guidance
on the data necessary to warrant IND submission. The review divisions are
organized generally along therapeutic class and can each be contacted using
the designated Pre-IND Consultation
List. (12/5/2006) 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 , 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 INDs include:
Back to TopLaws, Regulations, Policies and ProceduresThe 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 that 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 most regulations pertaining to food and drugs. The regulations document all actions of all drug sponsors that are required under Federal law.
Manual of Policies and Procedues (MaPPs) CDER's Manual of Policies and Procedures (MaPPs). MaPPS 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 IND sponsors include:
IND Forms and InstructionsForms for use in submitting INDs include:
Back to TopEmergency use of an Investigational Drug or Biologic
Emergency use requests:
Related Topics
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