Investigational New Drug IND , applications for

CFR - Part 312.33 discusses what is required for an Investigational New Drug (IND) application. Part 312.33 discusses the requirements for the annual reporting for the IND. This reporting requires you to create adverse event, death, and subject dropout summaries annually for any drug under an IND application. 

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. 

An Investigational New Drug (IND) application to the FDA seeks permission for a human chnical trial to be conducted. An IND apphcation is detailed under 21 CFR Part 312. The process for an IND is summarized in Fig. 8.2. 

The clinical drug development process required by the US FDA, arguably the most stringent in the world, starts with the investigational new drug (IND) application prior to human testing. It reveals information about all known compounds to be used and includes the description of the clinical research plan for the product as well as the protocol for phase I studies. Preclinical study results also need to be revealed. 

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. 

PrecUnical data are compiled in the Investigational New Drug (IND) application—a request for permission to initiate human studies—and submitted to the FDA for approval. The IND application requires full disclosure of all the precUnical study results as well as where and how the drug itself is manufactured and formulated to ensure quality and stability. The IND also contains pharmacology and toxicology data, evidence of desired and unwanted... 

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