Blog Post
22 November 2017
On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited...
Blog Post
10 March 2016
The U.S. Food and Drug Administration (FDA) and Amarin Pharma, Inc. (Amarin) have released a stipulation and settlement order that would resolve all causes of action raised in Amarin’s...
Blog Post
11 February 2015
On Monday, February 9, 2015, the Food and Drug Administration (FDA) published a revised draft guidance addressing disclosure of risk information requirements in direct-to-consumer (DTC)...
Blog Post
28 February 2014
Today, FDA announced the availability of a revised draft guidance, Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices (Revised Draft Guidance)....
Blog Post
12 November 2013
On October 29, 2013, FDA released a report titled Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development. In a post on FDA’s blog, FDA Voice,...
