Day: December 7, 2017

Since its announcement of four new guidance documents regarding regenerative medicine about a month ago, there has been a lot of confusion in the regenerative medicine industry. Some of FDA’s actions appear as if the Agency has decided to ignore most public comments it received in the recent years on the topic, indicating that FDA … Read more

This week FDA described its heavily hands-on approach for the approval of “Artificial Pancreas” to highlight how FDA reviewers could play an active role in approval of innovative new products. There are several lessons for other developers in this story and notes of caution as well. The automated insulin dosing system, commonly known as an … Read more