I recently led an initiative to communicate more proactively and frequently with the leaders of the FDA about issues specifically related to improving the agency’s focus on innovative biomedical and therapeutic technologies.
At San Diego’s Biocom, where I am CEO, we believe that both industry and regulators can benefit from an atmosphere of open communication and trust. Ultimately, we all benefit from an improved track record of product review and approval, compliance, and regulatory policy development. Over the course of this initiative, we learned that while there is nothing as important to product approval as a well-developed data package, it helps to follow a few basic tenets for working with FDA.
To read the full, original article click on this link: Five Tips for Building a Successful Relationship with the FDA | Xconomy
