The present Federal law necessitates that drugs have to be subject to the certified marketing applications before being distributed across the state. In that sponsors, will mostly desire to distribute the investigational drug in other regions and thus the drugs must acquire an exemption from the legal supplies. In this case, IND is the channel through which these sponsors usually acquire the exemption for the distribution of the drug from the FDA.

During the early development phase of a new drug, the main objective of the sponsors is to establish if the drug is sensibly safe for human use. In the case that the products display pharmacological action that justifies profitable development, the investigation is necessary. After a product has been classified as a viable applicant for additional development, then it allows the involved investors or sponsors to gather information and all the necessary details that are required to ensure that the drug does not expose the users to unreasonable threats even when utilized in the early phases of the clinical investigation. The main FDA’s role with respect to the development of a new product or drug commences at the point in which the involved sponsors which usually incorporate the possible marketers or manufacturers, after screening the component for pharmacological operation and acute harm from animals are willing to conduct a tests on the drug for clinical, therapeutic or even diagnostic ability for humans. In this case, the component shifts ownership under the FDA thus becoming a new drug that is subjected to a particular set of requirement for regulation.

With respect to the existence of an operational IND, then the sponsors of the application might be in need of making certain amendments or even introducing a new protocol as required in order to ensure that the clinical surveys are carried out while adhering to the protocols that are incorporated under the IND application. Sponsors are usually required to submit the amendments of new protocols or the possible changes to the already developed protocols prior to the implementation of respective amendments. In other words, this implies that some new studies might be initiated at that moment when the sponsors have submitted the proposed changes to the FDA for assessment and the new protocol or the proposed changes to the already existing one have acquired approval from the IRB (Institution Review Board) holding the obligation for evaluation and endorsement of the studies. In the case that the IND application investors desire to comment on the submission that has been made, then they are required to send a request with regard to such comments as while as the specific questions in which they wish that FDA should respond and address any further issues that might arise.

With regard to a new protocol then the sponsors are usually required to ensure that the submission is comprehensive and that it incorporates all the details. In that, the application has to be feasible and relevant to the product while allowing the FDA to initiate its investigation on the clinical applicability of the drug. Thus, the sponsors might, in this case, submit their investigation or finding IND while proposing a study on an unapproved drug that focuses on a specific patient population based on its findings. The anticipated outcome and applicability in the clinical field must be indicated on the submission. There is a procedure that is followed when submitting a new protocol to an open IND.