What Is the Legal Basis for an IND

The requirement for an Investigational New Drug application is defined in the law governing development of new drugs in the United States, i.e., the Federal Food, Drug and Cosmetic Act (FD&C Act). The FD&C Act became law in 1938, and it has had several major amendments since that time. Today, the fundamental requirements of the FD&C Act for new drugs are as follows:

Proof of safety

Substantial evidence of efficacy

Informative labeling for the product

Demonstration of manufacturing of the product to the desired strength, quality, purity, and identity

The FD&C Act requires that all drugs distributed in interstate commerce in the United States have proof of safety and substantial evidence of efficacy; an investigational drug (which by definition lacks such demonstration of safety and efficacy) may be administered to patients in the United States in order to gather evidence of safety and efficacy after such a drug obtains an exemption (i.e., an IND) for conduct of specific clinical studies for specific indications by specific clinical investigators in the presence of ongoing sponsor commitments to monitor these studies and provide certain information to the FDA.

The FD&C Act itself defines the requirement for an IND, but it does not provide more detailed information on the procedures and operational approaches to be used in drug development in order to satisfy these legal requirements. In order to provide operational details, subsequent to passage of the FD&C Act, the FDA developed the implementing regulations governing drug development. Most of these regulations are found in Title 21 of the Code of Federal Regulations.

The following list identifies the major regulations governing development of investigational drugs:

Part number

in Title 21

Regulation

50

Informed Consent

56

Institutional Review Boards

201

Prescription Drug Labeling

202

Prescription Drug Advertising

211

Current GMPs

312

Investigational New Drug Application

314

New Drug Applications

320

Bioavailability and Bioequivalence Requirements

Beyond these regulations, which are enforceable as law, the FDA provides guidance documents on the drug development process. These guidance documents take the form of guidelines, ''Points to Consider'' documents, and ''Information Sheets.'' Such guidances are informal communications from the FDA in that they reflect the FDA's best judgment at the time of their preparation, but neither the FDA nor sponsors are legally obligated to adhere to the provisions of guidances.

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