Important considerations 1. CRADAs are only suitable for collaborators who make significant intellectual contributions to the research project or who bring essential research materials or technical resources that are not available to the FDA elsewhere. CRADAs cannot attempt to direct or limit research in an FDA laboratory. Routine, conventional testing or research without collaborative intellectual input from both parties is not suitable for a CRADA.2. When reviewing a CRADA proposal, the FDA must determine whether the objectives of a proposed cooperation warrant the creation of a CRADA or whether its objectives are more adequately achieved through a purchase agreement, material transfer agreement, cooperation agreement, or other contractual mechanism. 3. The sole purpose of a CRADA cannot be to assist postdoctoral fellows and/or technicians, to obtain funds or to purchase equipment and/or accessories. Conversely, the only justification for a CRADA cannot be for an FDA laboratory to conduct research or testing for the employee.4. FDA scientists may have conflicts of interest to the extent that they act as project leaders in a contract or are empowered to make funding decisions as part of their CRADA research. FDA scientists may have conflicts of interest, as they are also regulatory auditors or have authority over regulatory decisions in a product area that cuts across the topic of CRADA research. Any real or manifest conflict of interest should be addressed during the verification and approval of CRADAs, as well as other conflicts of interest.5. Appropriate confidentiality requirements and short delays in the dissemination of research results are permitted under a CRADA, to the extent necessary for the protection of proprietary materials and intellectual property rights.6. The FDA is taking steps to ensure that outside organizations have equitable access to cooperation opportunities, federal technology licensing, and fda scientific expertise, paying special attention to small businesses and prioritizing those based in the U.S.
and agreeing to produce products developed under CRADA in the U.S. Equitable access to CRADAs is not considered to be the same as the notion of „open competition” as defined for contracts and small purchases. CRADAs, which explicitly attempt to direct NIH research, are not appropriate. In addition, when considering a CRADA proposal, care should be taken to ensure that targeted research is implicitly the net effect. For example, the more resources a laboratory comes from a CRADA, the less likely it is that the laboratory will follow other research opportunities outside of CRADA; The wider the scope of a CRADA research plan, the less a laboratory will be able to offer equitable access and interact with others. The achievement of this balance shall be taken into account in the decision-making process. It should therefore be taken into account that Cooperative Research and Development Agreements (CRADAs) are an exciting opportunity for NIH researchers to meet with their counterparts in industry and science as part of the joint pursuit of common research goals. Government scientists can use their own research resources and serve the NIH`s broadest mission to facilitate the development and commercialization of drugs and health products. Companies can also use their own R&D efforts, while collaborating on state-of-the-art research in NH.
CRADA is an agreement by which the FDA laboratory makes available personnel, services, facilities, equipment, or other resources — but no funding — for the performance of certain research or development efforts. . . .