Investigational new drugs regulations

Clinical Protocols and Investigator Information. Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks needs to be provided. In addition, information on the qualifications of clinical investigators, professionals (generally physicians) who oversee the administration of the experimental compound, to assess whether they are qualified to fulfill their clinical trial duties is needed. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations are also required. 

AIDSTRIALS (AIDS Clinical Trials). The AIDSTRIALS database [80] provides information about AIDS-related studies of experimental treatments conducted under the FDA s investigational new drug (IND) regulations. AIDSTRIALS contains information about clinical trials of agents undergoing evaluation for use against AIDS, HIV infection, and AIDS-related opportunistic diseases such as Pneumocystis carinii pneumonia (PCP). Detailed information is supplied... 

After completing preclinical testing, a company files an Investigational New Drug (IND) application with the regulators (the FDA in the U.S.), so that clinical studies in man can begin. The IND shows results of all experiments to this point, a detailed proposal for the clinical study, the expected mode of action for the drug, and any side effects observed. All clinical trials will also be reviewed and approved by the Institutional Review Board (IRB) at the clinic where the trials will be run. 

Eood and Drug Administration (EDA). Investigational New Drug Application. 21 Code of Federal Regulations Part 312. Washington DC National Archives and Records Administration, 1998. 

Three t)rpes of rmusual IND situations deserve special mention. First, the regulations contain a provision governing emergency use of an investigational new drug. Where FDA will permit such use by telephone or other rapid communication means. In these situations, the IND must subsequently be amended to reflect the new situation. Second, FDA will approve specific... 

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. 

Investigational New Drug (IND) application. The IND petition requires full disclosure of where and how the NME is manufactured and controlled for quality and stability. It also contains proposed analytical methods, pharmacology and toxicology data, and evidence of desired effects in disease models. The application lists proposed chnical investigators and contains complete human subject protocols. Under current regulations the FDA must provide a written response to the sponsor within 30 days after submission. The lack of a timely response is tacit approval for the sponsor to proceed to the clinic. 

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