With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more
2/17/2021
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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
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
What is new in the world of follow-on biologics?
Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more