Regulatory Affairs Associates Announces First Round Winners in the National Cancer Institute Expert FDA Regulatory Consultancy Program
14 of the finest National Cancer Institute (NCI) drug projects have been selected from among all NCI drug projects that applied for expert FDA consulting advice from Regulatory Affairs Associates (RAA) in Farmington Hills, Michigan. These projects have been judged extremely high in potential for successful FDA review based upon their innovative medicine and science. RAA will provide direction to move the projects expeditously into and through the FDA review process.
Stephen Goldner, President of RAA said: “Reducing time-to-market is often considered the best way to reduce costs and make American inventions more competitive around the world. We are honored that NCI has given us this responsibility. Now we can help these terrific medical researchers organize their work to coordinate with FDA drug approval policies.”
This research comes from many of the finest American universities and research centers, including: Tulane University Medical Center, Duke University Medical Center, MD Anderson Cancer Center, U.C. Berkley, Stanford Medical Center, Dartmouth University, U.C. San Francisco and University of Wisconsin.
Each cancer drug project has the potential to help many thousands of patients suffering from cancer; rapid FDA review is crucial to implement these transformational medical advances. Moving closer to FDA review and approval adds significantly to market capitalization of drug projects and represents another way that medical inventors, government and industry can cooperate to everyone’s benefit.
Each of the winning research companies will meet with RAA for one-on-one advice designed to align their research with FDA Best Practices Regulatory Process. This process enhances each company’s ability to obtain World Wide Regulatory Review and Approval in the most cost effective manner.
RAA provides expert regulatory consulting for companies in North America, Europe, Asia, Oceania and the Middle East Region. Regulatory Affairs Associates is one of the foremost advisors to drug and medical device companies, universities and independent inventors. RAA was chosen by the National Cancer Institutes/NIH to be the sole source provider of FDA consulting advice to these selected NCI-funded projects.
For more information about RAA contact Stephen Goldner at 248-747-8008 or by email at sgoldner@regaffairs.net. For more information on the NCI Regulatory Assistance Program please visit http://www.regaffairs.net/login.html.
Contact:
Michael Tomasovich
mtomasovich@regaffairs.net
313 563 5934
 |
Subscribe to this comment's feed