ERA

IND and SAE Reporting

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An Investigational New Drug Application (IND) needs to be filed with the FDA in order to conduct clinical trials in the USA and later apply for authorisation of interstate commerce of a new medicinal product. INDs must contain information on manufacturing processes, animal pharmacology and toxicology studies, clinical protocols and the qualifications of clinical investigators.

INDs can be submitted in eCTD or paper format. As FDA plans to mandate electronic submissions, it is highly recommended to switch from paper to electronic dossiers in a timely manner.

Throughout the life of an IND several amendments will be submitted to FDA to update the information in the dossier. One type of submission is an IND safety report (i.e. 7- or 15-day expedited report) where the sponsor notifies FDA and all participating investigators about potentially serious risks that manifested as adverse events during the conduct of clinical trials or any other source. Additionally, annual IND safety reports are required and FDA needs to be notified of any change to the clinical protocol.


ERA can support you in compiling your electronic IND submission in eCTD format according to relevant guidelines as well as submitting the electronic application through FDA's Electronic Submission Gateway (ESG).


How can ERA's eCTD group help?

Are you looking for other product development consulting services independent of eCTD?

For further information on other consulting services please see: www.eraconsulting.com