U.S. Food and Drug Administration Center for Drug Evaluation and Research |
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Drug Applications |
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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. 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 Guidance documents to help prepare INDs include:
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21CFR Part 312 | Investigational New Drug Application |
21CFR Part 314 | INDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval) |
21CFR Part 316 | Orphan Drugs |
21CFR Part 58 | Good Lab Practice for Nonclinical Laboratory [Animal] Studies |
21CFR Part 50 | Protection of Human Subjects |
21CFR Part 56 | Institutional Review Boards |
21CFR Part 201 | Drug Labeling |
21CFR Part 54 | Financial Disclosure by Clinical Investigators |
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:
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Forms for use in submitting INDs include:
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FDA proposes rules overhaul to expand the availability of experimental drugs. The Agency also clarifies permissible charges to patients. FDA News (12/11/2006)
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.
For assistance in obtaining unapproved cancer drugs, please see Access to Unapproved Drugs.
Federal
Register notice for Emergency Use of an Investigational New Drug;
Technical Amendment
Directions to Sponsors of Emergency Investigational New Drug (EIND) Application. From the Office of Antimicrobial Products, Division of Antiviral Products (11/29/2005)
Emergency use requests:
For investigational biological products regulated by CBER, call 301-827-2000.
For all other investigational drugs, call 301-827-4570.
After working hours, call FDA’s Office of Emergency Operations at 301-443-1240.
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FDA/Center for Drug Evaluation and Research
Last Updated: Decmeber 28, 2007
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