The National Cancer Institute has awarded a contract to Regulatory Affairs Associates of Farmington Hills to undertake a one-year program, with two optional continuation years.
This contract provides regulatory consulting for up to 100 NCI drug development programs.
RAA was selected for its many years of experience, dedicated staff, and innovative approach to drug development. RAA has worked with many cancer development drugs and recently guided an NCI sponsored oral oncology drug through FDA oversight to clinical testing.
Every drug researched and developed through National Cancer Institute’s program funding must be approved by FDA in order to become a treatment option for physicians and patients. The expert FDA regulatory advisors at RAA know the testing and data presentations that FDA requires. Now they will be available to programs that have NCI research funding. This reduces the time and money needed for testing by creating collaborations between FDA and the NCI researchers. It is expected to bring more cancer cures to patients sooner.
RAA will direct NCI Small Business Innovation Research and Small Business Technology Transfer grant recipients to navigate the complicated regulatory path to FDA approval and commercial acceptance. It is one of the NIH’s translational medicine implementation practices; to move break-through drug research from the research labs, to controlled clinical tests, to medical practice for cancer patients. Cancer researchers will begin receiving this assistance very quickly.
The NCI drug programs will follow a very simple application process to take advantage of this opportunity. The projects will be reviewed and regulatory experts assigned to create a regulatory process tailored to each project. Progress will be tracked and improved upon as the projects proceed through their rigorous scientific and medical testing process. The process will be benchmarked to ensure ‘best practices’ results; offers researchers increased opportunities to engage with knowledgeable and innovative drug developers.
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