FDA Support for Developing Products for Rare Diseases & Conditions

The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.  In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. The office also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups.Continue reading

Beware of Trademark Scams

Many trademark applicants are getting official looking notices from scam artists. These notices make it appear that the notice is from the United States Patent and Trademark Office. Unless carefully examined these notices can fool just about anyone.Continue reading

Find high quality clinical research sites in Arizona with ASU CONECTR

 

ASU CONECTR, an established network of high quality clinical research sites in Arizona, assists organizations in the placement and conduct of clinical trials.  Committed to excellence in clinical research processes, CONECTR sites have a track record of rapid study start-up, faster contract and regulatory turnaround times, and successful patient enrollment.   For more information about CONECTR, go to www.conectr.org .Continue reading

The Next Steps After SBIR/STTR Reauthorization

This year, technology and business organizations, including AZBio worked together with Congress to reauthorize the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) program. Sean Greene, Associate Administrator for Investment and Special Advisor for Innovation at the U.S. Small Business Administration, has recently shared his thoughts on what comes next on the SBA Community Blog…Continue reading