Ind cover letter fda

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Video explanation. This initial IND submission template is designed for sponsor investigators conducting 'simple' clinical studies where commercially marketed drugs are being evaluated. Maintain all of the headings in this document. If some are not applicable, simply state this under the appropriate headings. IND Template.
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Dr. Joseph Mercola Ordered to Stop Illegal Claims

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Dr. Joseph Mercola Ordered to Stop Illegal Claims | Quackwatch

Once an IND application is in effect, the sponsor of the application may amend the application as needed to ensure that the clinical investigations are conducted according to protocols included in the IND application. The sponsor-investigator may initiate the new protocol once the following two conditions are met:. The sponsor-investigator may comply with these two conditions in either order. When several submissions with minor amendments are expected within a short period, sponsors are encouraged, to the extent feasible, to include all amendments in a single submission. Any specific technical information referenced in an IND application amendment as already submitted to FDA in the original IND application is expected to be identified by name, reference number, volume, page number, and date of submission.
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Registering the clinical trial at clinicaltrials. Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations. IND sponsors are expected to submit protocol amendments for new protocols or changes to existing protocols to FDA before implementing the respective changes.
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