So, Who Would Like Some PIK-3 ?

However, with the initial formatting considerations, the cost for the initial submission of an IND or IDE may not significantly differ between paper and electronic format. Instead, we expect that the resources for IND and IDE maintenance activity (the majority of our FDA submission volume) will be significantly reduced Selleckchem Lenvatinib by eSub capability. Therefore, our long-term expectation is to save both money and time by converting to eCTD. By statute, INDs and IDEs have a 30-day review window by which FDA must formally respond. Electronic submissions are rapidly funneled to the division and Regulatory Project Manager to begin assignment and review. In contrast, it is estimated that a paper IND could take up to 2 weeks to reach the desk of a Regulatory Project Manager.[11] Given FDA's 30-day timeline for IND/IDE review, electronic submissions could more than double the time allowed for FDA review and even for communication with the academic sponsor-investigator. Such communications may help avoid select Clinical Hold issues being imposed on the IND. eSubmission format therefore benefits both the sponsor and FDA. In 2011, 17.2% of IND submissions to CDER were ��Research�� INDs from an academic sponsor.[11] Following broad eCTD adoption by industry, paper INDs from academia will become a growing operational burden to FDA. In addition, FDA reviewers strongly prefer electronic format, and there PIK-3 is some evidence that eCTD format (vs. paper) enables a more favorable regulatory review.[12] As the preferred and increasingly adopted submission format, there are likely both quantitative and qualitative benefits of eCTD adoption for Agency interaction. Given the risk and rising cost of R&D, industry is increasingly approaching academia for licensing and partnering opportunities. This cooperation could involve eventual NDAs/BLAs for new drugs or biologics or 510k/PMA submissions for new devices. Given that drug repurposing research is common Small Molecule Compound Library in academic health centers, industry partnerships could also likely utilize the 505(b)(2) NDA pathway. Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act was established by the Hatch�CWaxman Amendments of 1984 and allows approval of NDAs containing investigations of safety and effectiveness that were not conducted by/for the applicant. The 505(b)(2) can avoid unnecessary duplication of studies already performed on the approved drug, but sponsors must provide data to ensure that the differences from the approved drug (like a new formulation or patient population) do not compromise safety and effectiveness. Because approval can rest in part on data already accepted by the FDA or otherwise available in the public domain, fewer and smaller studies may be required which mitigates risk, costs, and development time.