CRADA is an agreement under which the FDA laboratory contributes to the realization of certain research or development efforts in personnel, services, facilities, equipment or other resources, but not funding. The CRADA partner is involved in all necessary funding for the project, as well as staff, services, facilities, equipment or other resources. A Research and Development Cooperation Agreement (CRADA) is a written agreement between a private company and a government agency to work together on a project. It is one of the most important mechanisms used by federal laboratories to work with non-federal partners to achieve technology transfer objectives. It should be a flexible mechanism that can be adapted to a large number of cooperative efforts between federal and non-federal organizations and can be implemented relatively easily in a relatively short period of time. As a technology transfer mechanism, CRADA is a very useful tool for transferring federally funded research and development to the private sector. CRADA offers non-federal staff the opportunity to negotiate an exclusive or non-exclusive license for any CRADA Subject Invention resulting from the research. CRADA is the only agreement that authorizes an IP licensing option developed during a collaborative research project. CRADAs define the conditions for sponsored collaborative research, usually with non-federal industry partners, and are specifically designed to protect past party inventions, while allowing government and private sector research partners to negotiate the management of new discoveries or intellectual property that may result from cooperation. Important considerations 1.

CRADAs are only suitable for collaborators who make significant intellectual contributions to the research project or who provide essential resources for research or technical resources that the FDA could not reasonably have made available to the FDA. CRADAs cannot attempt to direct or limit research in an FDA laboratory. Routine, conventional testing or research without collaborative intellectual contribution from both parties is not suitable for a CRADA.2. In reviewing a proposed CRADA, the FDA must determine whether the objectives of a proposed cooperation warrant the creation of a CRADA or whether its objectives are best achieved by a purchase contract, a material transfer agreement, a cooperation agreement or other contractual mechanisms. 3. The sole purpose of a CRADA cannot be to assist postdoctoral fellows and/or technicians, receive funds or purchase equipment and/or supplies. Conversely, the only justification for a CRADA can only be an FDA laboratory conducting research or testing for staff.4 FDA researchers may have conflicts of interest because they act as project managers for a contract or have funding decisions in their CRADA research. FDA researchers may have conflicts of interest, as they are also regulatory auditors or have the jurisdiction to make regulatory decisions in a product area that intersects with the subject of CRADA research.

Posted Sunday, December 6th, 2020 at 2:39 am
Filed Under Category: Uncategorized
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