Newsletter - December 7, 2017
FDA Takes Unconventionally Hands-On Role to Approve New Technology
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. Read More
Regenerative Medicine and FDA: Echo Chamber or Calm before the Storm?
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.... Read More
FDA Takes Unconventionally Hands-On Role to Approve New Technology
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. Read More
Regenerative Medicine and FDA: Echo Chamber or Calm before the Storm?
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.... Read More
