Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines.
Key Points:
..Congress authorized FDA to collect increased total annual user...more
The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens.
On December 13, 2016, President Obama signed into...more
New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016.
On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more
The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion.
On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more
FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn?
On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more